[Senate Hearing 116-549]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 116-549

                     ALZHEIMER'S: NEW DIRECTIONS IN
                   BIOMEDICAL RESEARCH AND CAREGIVING

=======================================================================

                                HEARING

                               BEFORE THE

                       SPECIAL COMMITTEE ON AGING

                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS


                             FIRST SESSION

                               __________

                             WASHINGTON, DC

                               __________

                             APRIL 2, 2019

                               __________

                           Serial No. 116-05

         Printed for the use of the Special Committee on Aging
         
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        Available via the World Wide Web: http://www.govinfo.gov
        
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                    U.S. GOVERNMENT PUBLISHING OFFICE                    
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                       SPECIAL COMMITTEE ON AGING

                   SUSAN M. COLLINS, Maine, Chairman

TIM SCOTT, South Carolina            ROBERT P. CASEY, JR., Pennsylvania
RICHARD BURR, North Carolina         KIRSTEN E. GILLIBRAND, New York
MARTHA McSALLY, Arizona              RICHARD BLUMENTHAL, Connecticut
MARCO RUBIO, Florida                 ELIZABETH WARREN, Massachusetts
JOSH HAWLEY, Missouri                DOUG JONES, Alabama
MIKE BRAUN, Indiana                  KYRSTEN SINEMA, Arizona
RICK SCOTT, Florida                  JACKY ROSEN, Nevada
                              ----------                              
            Sarah Khasawinah, Majority Acting Staff Director
                 Kathryn Mevis, Minority Staff Director
                         
                         
                         C  O  N  T  E  N  T  S

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                                                                   Page

Opening Statement of Senator Susan M. Collins, Chairman..........     1
Opening Statement of Senator Robert P. Casey, Jr., Ranking Member     3

                           PANEL OF WITNESSES

Mary Dysart Hartt, Family Caregiver, Hamden, Maine; Accompanied 
  by Michael Hartt...............................................     5
Clay Jacobs, Executive Director, Greater Pennsylvania Area 
  Chapter of the Alzheimer's Association, Wilkes-Barre, 
  Pennsylvania...................................................     7
Sharon Fekrat, M.D., Professor of Ophthalmology and Associate 
  Professor of Surgery, Duke School of Medicine, Durham, North 
  Carolina.......................................................     9
Richard J. Hodes, M.D., Director, National Institute on Aging, 
  National Institutes of Health, Bethesda, Maryland..............    11

                                APPENDIX
                      Prepared Witness Statements

Mary Dysart Hartt, Family Caregiver, Hamden, Maine; Accompanied 
  by Michael Hartt...............................................    37
Clay Jacobs, Executive Director, Greater Pennsylvania Area 
  Chapter of the Alzheimer's Association, Wilkes-Barre, 
  Pennsylvania...................................................    41
Sharon Fekrat, M.D., Professor of Ophthalmology and Associate 
  Professor of Surgery, Duke School of Medicine, Durham, North 
  Carolina.......................................................    45
Richard J. Hodes, M.D., Director, National Institute on Aging, 
  National Institutes of Health, Bethesda, Maryland..............    51

                       Statements for the Record

Alzheimer's Impact Movement Assocation...........................    67
Slide presented by Sharon Fekrat, M.D., Professor of 
  Ophthalmology and Associate Professor of Surgery...............    70
Slides presented by Richard J. Hodes, M.D., Director of National 
  Institute on Aging and National Institutes of Health...........    71

 
                     ALZHEIMER'S: NEW DIRECTIONS IN
                   BIOMEDICAL RESEARCH AND CAREGIVING

                              ----------                              


                         TUESDAY, APRIL 2, 2019

                                       U.S. Senate,
                                Special Committee on Aging,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 9:39 a.m., in 
Room 106, Dirksen Senate Office Building, Hon. Susan M. 
Collins, Chairman of the Committee, presiding.
    Present: Senators Collins, Tim Scott, McSally, Hawley, 
Braun, Rick Scott, Casey, Blumenthal, Jones, Sinema, and Rosen.

                 OPENING STATEMENT OF SENATOR 
                   SUSAN M. COLLINS, CHAIRMAN

    The Chairman. The hearing will come to order.
    Good morning, and welcome to all the individuals, families, 
and organizations from all across the country who have come to 
our Nation's Capital to advocate for better treatments and 
ultimately a means of prevention and a cure for Alzheimer's 
disease as well as for more support for caregivers.
    In the fight against Alzheimer's, you are the champions. 
Your advocacy has ushered in an era of hope paired with action 
against this devastating disease. Since we gathered last June, 
through your diligent work, in a matter of months, we 
successfully pushed the landmark BOLD Infrastructure for 
Alzheimer's Act across the finish line.
    Today this law marks a new public health approach for this 
disease. It will promote early diagnosis and improve treatment 
and care for millions for whom the disease is a reality day in 
and day out.
    The statistics remain stark. A new CDC report shows that 
the rate of Americans dying from dementia has more than doubled 
in our country since the year 2000. An estimated 5.8 million 
Americans are living with Alzheimer's, costing our Nation $290 
billion a year, including $195 billion in costs to Medicare and 
Medicaid.
    If we continue along this trajectory, Alzheimer's is 
projected to claim the minds of nearly 14 million Americans and 
surpass $1 trillion in costs by the year 2050.
    While scientists and medical professionals are working hard 
on an effective treatment and cure, recent clinical trials have 
unfortunately ended in a string of failures.
    Just last month, two more major trials targeting amyloid 
deposits in the brain were halted. For decades, many 
researchers have been targeting amyloid, the hallmark sign of 
Alzheimer's disease.
    Today, due to advancements in brain imaging, we know that 
some people exhibit rampant amyloid plaques and yet never 
develop the disease. While amyloid remains an important part of 
ongoing research and I remain hopeful that the new trials 
starting earlier in the disease process will produce better 
news, the record funding that we have provided will allow our 
medical researchers to pursue so many other promising 
approaches.
    I am delighted that last year, a bipartisan coalition, of 
which every member on this Committee is a part, worked hard to 
achieve a $425 million increase in Federal funding for 
Alzheimer's research. That was the largest increase in our 
Nation's history, and I can see Dr. Hodes smiling broadly at 
that.
    With our total investment at more than $2 billion for 
Alzheimer's this year, we are on a strong path forward, and we 
are not going to turn back.
    This year, as we have before, I expect Congress to once 
again reject the President's unwise request to cut the funding 
for the National Institutes of Health.
    The robust funding that Congress has provided is enabling 
scientists to explore a myriad of new pathways that could lead 
to earlier detection and potential therapies. From the ocular 
and the cardiovascular to the genome and the microbiome to the 
immune and the lymphatic system, researchers are leaving no 
system unexamined and no cell unturned.
    While we continue to forge ahead to accelerate biomedical 
research, we face the reality that this disease is affecting 
millions of American families. BOLD, now signed into law, marks 
a milestone toward building the public health infrastructure we 
need to better support individuals, families, and communities.
    Support can make all of the difference. Tom O'Connor, a 
caregiver from Portland, Maine, who is with us today, told us, 
``When we got the diagnosis, we were shocked and did not know 
where to start.''
    When he was referred to community partners, he received the 
information he needed and was able to put a plan in place to 
make the time ahead better for himself and for his wife, who is 
battling Alzheimer's.
    Diagnosis is the first step that can empower individuals 
and families to understand changes in the brain, but developing 
a plan for care can make the journey so much better. Care plans 
can also help to reduce comorbidities, prevent 
hospitalizations, and improve life not only for those living 
with the disease, but also for their caregivers.
    As the BOLD approach spreads to communities across America, 
we must continue to develop Federal policies to better support 
all Americans with Alzheimer's and their families.
    Last year, I heard from constituents facing early onset 
Alzheimer's that it can be difficult to access necessary 
supports simply due to not meeting the age thresholds for 
various Federal programs.
    This year, I am leading the reauthorization of the Older 
Americans Act along with my Ranking Member, Senator Casey.
    Last week, I introduced a bill that would ensure that key 
services in the Older Americans Act, such as the National 
Family Caregiver Support Program, will also serve those with 
Alzheimer's who are younger than age 60.
    Whenever I ask family caregivers, which included my own 
mother, about their greatest needs, the number one, request 
that I hear is for more respite care. Today, I am also 
introducing the Lifespan Respite Care Act with Senator Tammy 
Baldwin to help communities and States provide respite care for 
families.
    From accelerating research to advancing care, every year 
that we gather as one sea of purple, we make waves, and by the 
way, I want to thank Michael Hartt for giving me a sash today 
to wear. Thank you, Michael.
    From accelerating research to advancing care, we are making 
progress. While Alzheimer's robs our loved ones of precious 
memories, I stand with you to do everything we can to make 
Alzheimer's itself a memory 1 day.
    Thank you. I am not delighted to turn to another fierce 
advocate for research for this disease, the Ranking Member, 
Senator Casey.

                 OPENING STATEMENT OF SENATOR 
              ROBERT P. CASEY, JR., RANKING MEMBER

    Senator Casey. Thank you, Chairman Collins, for, of course, 
holding this hearing today, one of the highlights of the year 
in terms of hearings. I do not know of a hearing throughout the 
year that has this much energy and enthusiasm and this kind of 
a crowd and that kind of applause.
    I also want to thank Chairman Collins for her enduring 
leadership in the fight to find a cure for Alzheimer's disease.
    I want to extend our gratitude as well to all the advocates 
in the room today, all of the caregivers, family members who 
have traveled across the Country to be in this hearing room 
with us today.
    Few American families are unaffected by this vicious 
disease. Indeed, over 5.8 million people over the age of 65 
currently live with Alzheimer's disease. Approximately 280,000 
of those people are Pennsylvanians, and those number are 
rising.
    We know that the impact it has on the person diagnosed, but 
also the impact on their family can be devastating, and that 
is, of course, an understatement.
    We must support efforts to find a cure.
    I am pleased every year to be able to lead the 
appropriations letter in the Senate with Senator Burr to 
advocate for more research funding at the National Institutes 
of Health and to join Chairman Collins in ensuring robust 
funding for Alzheimer's disease research and in this case, of 
course, specifically in her work on the Appropriations 
Committee, and we commend her for that.
    Until there is a cure, we must do everything in our power 
to make sure that people receive the best possible care, so we 
focus on both finding a cure, but also on ensuring quality 
care.
    We know that this disease impacts different people 
differently, so our efforts must take into account people who 
are diagnosed at younger ages, people with disabilities, people 
from diverse backgrounds, and people living in both urban and 
rural settings.
    For example, people who are diagnosed at younger ages and 
are still working may have difficulty knowing where to turn for 
help because many essential supports are more commonly 
advertised to seniors. That is why I joined with Senator 
Collins, Senator Jones, who is with us today, Senator Capito in 
introducing the Younger-Onset Alzheimer's Disease Act to ensure 
that people younger than age 65 have access to counselors and 
support groups to help them navigate the health care system and 
plan for their long-term care needs.
    A subset of the people diagnosed at these younger ages are 
of course people with disabilities. For example, nearly half--
half--of all people with Down Syndrome will develop Alzheimer's 
disease in their lifetime; 30 percent of these Americans will 
be diagnosed before the age of 50.
    Research and clinical trials must include people with 
disabilities to ensure their needs are met in the quest for 
treatment and a cure.
    I would like to thank Senator Collins again for agreeing to 
work with me on policies that would address this specific 
disparity among people with disabilities.
    We also know that African Americans are two times--two 
times more likely than their white counterparts to develop 
Alzheimer's disease, and the Hispanic and Latino populations of 
America are one and a half times more likely to develop 
Alzheimer's disease. We must understand why and what can be 
done about those issues.
    People living in rural areas may not live near a major 
medical center or a research facility, which makes it harder 
for them to participate in research studies or clinical trials.
    We must tackle this disease from every angle, from 
continuing our research for a cure to ensuring medical 
professionals and community organizations can provide the best 
care possible to every American with Alzheimer's disease.
    I look forward to our witnesses' testimony today and the 
important conversations we will have. Thank you very much.
    The Chairman. Thank you, Senator Casey.
    Before we turn to our great panel of witnesses, we are 
going to start with a video so that we can hear directly from 
people around the country who are living with Alzheimer's.
    I want to thank the Alzheimer's Association for providing 
us with their voices.
    [Video played.][Video may be viewed at aging.senate.gov/
hearings]
    Those thoughts about diagnosis and insights about the path 
forward will help to frame our discussion today.
    Now I am pleased to turn to our witnesses. First, I am 
delighted to welcome from the great State of Maine, Mary Dysart 
Hartt and Michael Hartt, former business owners from Hampden, 
Maine.
    Today Mary is the caregiver for her husband, Mike, who was 
diagnosed 4 years ago at the age of 62. Now, Mrs. Hartt is 
known across the State of Maine for her famous Pies for a 
Purpose, which are Purpleberry pies. Yes, they are baked and 
sold to raise awareness about Alzheimer's.
    Mrs. Hartt has been honored as Restaurateur of the Year by 
the Maine Restaurant Association. She is also a photographer 
and a runner, and next month, she will run in the Boston 
Marathon and is fundraising for Alzheimer's research.
    Next, I would like to turn to our Ranking Member to 
introduce our witness from the Commonwealth of Pennsylvania.
    Senator Casey. Thank you, Chairman Collins.
    I am pleased to introduce Clay Jacobs. Clay is the 
Executive Director of the Greater Pennsylvania Chapter of the 
Alzheimer's Association. Clay is from North Abington Township, 
which happens to be Lackawanna County, where I live. It had 
nothing to do with is presence here today, but it certainly 
helped.
    Clay's wife, Becky, is also with us today. We are grateful 
that Becky took the time to travel to Washington.
    Clay is a graduate of a great Pennsylvania institution of 
higher education, Westchester University. He also told me 
earlier that he is a graduate of Abington Heights High School.
    In his current position, Clay works to support people 
living with Alzheimer's disease and their families through 
direct services, support, and education programs.
    I also want to welcome the large contingent of advocates 
who are in the audience today from Pennsylvania and across the 
country. Thank you for making the journey to be with us, and, 
Clay, thank you for being with us today. We look forward to 
your testimony.
    The Chairman. Our next witness, Dr. Sharon Fekrat, is a 
professor of Ophthalmology and associate professor of Surgery 
at Duke University School of Medicine. She also serves at the 
Durham VA Medical Center. She has coauthored more than 130 
publications in medical journals and 45 textbook chapters.
    Finally, we will hear from Dr. Richard Hodes, the Director 
of the National Institute on Aging at the National Institutes 
of Health. Dr. Hodes will provide an overview of the 
advancements in Alzheimer's research across the NIH and discuss 
partnerships with industry to accelerate therapies. He will 
also share new NIH research on supporting caregivers.
    I want to thank you all for joining us, and we will start 
with Mary Hartt.

        STATEMENT OF MARY DYSART HARTT, FAMILY CAREGIVER

    Mrs. Hartt. Thank you, Chairman Collins.
    The Chairman. We are going to have your mic turned on for 
you.
    Mrs. Hartt. I had a plan, and then I did not do it.
    Chairman Collins, Ranking Member Casey, and members of the 
Committee, thank you for the opportunity to testify about my 
experiences as a caregiver for my late mother and now my 
husband, Mike, who is currently living with Alzheimer's 
disease.
    Mike was diagnosed at age 62. My hope is that, in sharing 
our story, others who are impacted by this disease will feel 
less alone and understand that with proper supports, there is 
life after a diagnosis.
    Mike was 58 when I started noticing that things did not 
seem quite right. After living on our family farm since 1977, 
daily tasks like running the tractor became a challenge. During 
that same time, I was part of a family care team caring for my 
mom who was living with dementia. She was a brave woman who 
started our family owned business, Dysart's, with my father 52 
years ago, and for 52 years, our business has been open 24/7, 
so you can gather how brave she was to start that.
    My two brothers and I are very proud to have carried on our 
parents dream into the third generation. I began to see 
similarities in the challenges both Mike was facing and decided 
to reach out to our family doctor who agreed to help me monitor 
Mike for changes. For 4 years, we continued on this path, with 
things coming to a head when Mike was 62 and agreed to be 
tested.
    After incorrectly being diagnosed with frontotemporal 
dementia, or FTD, we received a diagnosis of younger-onset 
Alzheimer's from Mass General Memory Clinic in Boston. We are 
so thankful for the care we received at Mass General, and 
following the diagnosis, our lives changed significantly.
    Mike had owned a business that manufactured log homes. He 
was our money manager. After the diagnosis, we sold our farm 
where we had lived for nearly 40 years and simplified our life. 
The farm had a half-mile-long driveway, and it snows 
occasionally Maine.
    At 63, Mike volunteered to give up driving, a freedom that 
he really loved.
    Before Mike was diagnosed, we were not familiar with 
younger-onset Alzheimer's disease but had had some knowledge of 
Alzheimer's and dementia through the experience of caring for 
my mother.
    One common assumption about this disease is that life 
completely stops. While we have faced unique challenges as we 
have tackled this disease, we continue to move forward with our 
lives as best we can.
    In just 2 weeks, as Senator Collins says, I am going to be 
running the Boston Marathon with a charity number for the 
Alzheimer's Association to help rid the stigma of this disease. 
Too often, Alzheimer's is talked about in terms of cognition 
and memory, but it is much more.
    In Mike, I see it affect his emotions and temperament. If 
someone is diagnosed with cancer, people automatically rally 
around to offer support and guidance. An Alzheimer's diagnosis 
is sadly not the same, but there is nothing to be ashamed 
about. We cannot hide behind a diagnosis if we want to make 
progress.
    The staff at Mass General made clear that this disease is 
something that is meant to be taken day by day, to be 
approached with humor and a grasp of reality. Our doctor told 
us, ``Do not worry about tomorrow. Enjoy today.'' That is how 
we have chosen to live our life.
    Thanks to our providers and the support we received at the 
Alzheimer's Association, Maine Chapter, we have begun 
fulfilling wishes on our bucket list. Lucky for Mike, most of 
them have been fishing adventures. After more than 40 years of 
marriage, I took Fly Fishing 101, but I cannot out-fish him 
yet.
    However, I know these adventures are not typical for 
everyone, especially those without a care plan. For us, this 
plan came in pieces and with the help of our team of care 
providers at Mass General.
    Mike's diagnosis at 62 was a shock, but working with the 
team of care providers gave us time to talk through the reality 
of the situation and plan for the challenges that lie ahead.
    We continue to have regular visits, and at our last 
appointment, we had the conversation about giving up power of 
attorney, something I would never have thought to seek but was 
part of our plan.
    Thank you, Chairman Collins, for introducing the Improving 
Hope for Alzheimer's Act. It will make a difference in the 
lives of people living with Alzheimer's disease and other 
dementias and their families.
    I think a lot about how lucky we have been in our life to 
be able to care for ourselves in this next phase. For many 
people with younger onset, that is not the reality. The 
services and supports----
    [Mr. Hartt points to timer.]
    I think he is giving me a time.
    The Chairman. He is doing my job.
    Mrs. Hartt. There you go.
    The services and supports that are there for those 60 years 
and older are vast compared to those that are available to the 
population in the Alzheimer's and dementia community who have 
not yet reached that age.
    Thank you, Chairman Collins, Ranking Member Casey, Senator 
Jones, and Senator Capito for leading the Younger-Onset 
Alzheimer's Disease Act, which would help those with younger-
onset with supports and services.
    Throughout the last few days, Mike and I have joined our 
Alzheimer's Association, Maine Chapter, along with 12,000 
advocates from across the Nation to make a difference in our 
Nation's Capital.
    I am here today because I am the wife, caregiver, friend, 
and daughter of Alzheimer's. We all are, and we must remain a 
strong and a resilient voice for those who have lost theirs.
    Thank you very much.
    The Chairman. Mary, you and Mike are truly an inspiration, 
and I thank you both for being here.
    Mr. Jacobs.

         STATEMENT OF CLAY JACOBS, EXECUTIVE DIRECTOR,

               GREATER PENNSYLVANIA AREA CHAPTER

                OF THE ALZHEIMER'S ASSOCIATION,

                   WILKES-BARRE, PENNSYLVANIA

    Mr. Jacobs. Chairman Collins, Ranking Member Casey, and 
members of the Committee, I am Clay Jacobs, and I am the 
Executive Director of the Greater Pennsylvania Chapter of the 
Alzheimer's Association.
    Thank you for the opportunity to testify before the 
Committee on how we are working to support persons living with 
Alzheimer's disease, related dementias, and their families.
    Currently, 5.8 million Americans are living with 
Alzheimer's, and without significant action, nearly 14 million 
may have the disease by 2050. More than 16 million unpaid 
caregivers are supporting and caring for these individuals at a 
cost of $234 billion. In my home State of Pennsylvania, 280,000 
older individuals have Alzheimer's today, and in just a few 
years, 320,000 will likely be affected.
    Among the millions of individuals living with Alzheimer's, 
we know that there are communities who are disproportionately 
affected but remain underserved. Older African Americans are 
approximately twice as likely to have Alzheimer's or other 
dementias as older whites, and older Hispanics are about one 
and one half times as likely to be affected.
    Another population that is often under-recognized and 
underserved is the approximately 200,000 individuals under the 
age of 65 who have younger-onset Alzheimer's disease. The need 
to reach everyone affected will grow significantly in the 
coming years, and the Alzheimer's Association is working to 
reach as many of those people as possible.
    Alzheimer's is also a local disease, and our nationwide 
network of chapters serve to respond to the specific needs in 
their communities.
    To address the unique challenges of younger Pennsylvanians 
living with Alzheimer's, we offer early stage education and 
support groups throughout the Commonwealth to promote social 
engagement in local communities by partnering with museums, 
local tourism boards, libraries, and other organizations.
    We also work with the Pennsylvania Department of Aging to 
train facilitators for memory cafes and a variety of other 
services.
    In spite of these efforts to support this population, we 
know that they simply do not have access to many of the 
services they need.
    The Alzheimer's Association is grateful to Chairman 
Collins, Ranking Member Casey, Senator Jones, and Senator 
Capito for introducing the Younger-Onset Alzheimer's Disease 
Act.
    To reach other underserved populations in the Pennsylvania 
Chapter of the Alzheimer's Association, we conduct faith-based 
outreach and community education in partnership with a large 
African-American sorority, Alpha Kappa Alpha. We have recruited 
and deployed Spanish-speaking volunteers for health fairs, 
education programs, and support groups.
    We have actually had the great pleasure of working with 
Ranking Member Casey's staff on a number of these efforts.
    With our local area Agency on Aging, we work to reach 
Chinese, Korean, and Vietnamese organizations, attending their 
meetings and health fairs, working with interpreters when 
needed.
    I would actually like to share an example of how important 
it is to reach the variety of communities impacted by 
Alzheimer's and why outreach matters.
    Ruben Deoleo was born in the Dominican Republic. He moved 
to Pennsylvania in his 20's to serve as a minister, a drug and 
alcohol counselor, and a motivational speaker for the Dauphin 
County Prison. Memory problems, however, began to affect his 
life's calling. After losing several jobs, his wife, Rosayna, 
asked Ruben to see a doctor. For over 2 years, they grappled 
with what was happening and, just 4 months ago, he was 
diagnosed with Alzheimer's at the age of 58. They struggled 
with the diagnosis and, in particular, the fact that it was an 
untreatable illness.
    However, when Ruben learned about an Early Stage Engagement 
group at Lancaster General Health-Penn Medicine and that other 
individuals living with the disease cope and can live well, he 
decided to fight back. Ruben has a sense of purpose as a member 
of the group. He is energized, and he wants to create the same 
opportunities for others. He is now a volunteer for the 
chapter, helping the Spanish-speaking community to understand 
Alzheimer's and the resources that are available. Ruben is 
getting valuable support while also reaching others.
    A constant theme throughout all of our outreach is the 
importance of care planning after diagnosis. It is essential to 
learning about medical and non-medical treatments, clinical 
trials, and support services. These services result in fewer 
hospitalizations and emergency room visits and a higher quality 
of life.
    This is also true for caregivers, who too often find 
themselves as the plan, with little support after diagnosis.
    The association was grateful for the support of Members of 
Congress who sponsored or cosponsored the HOPE for Alzheimer's 
Act in the 114th Congress and to the Centers for Medicare and 
Medicaid Services for now covering care planning services. 
However, access to services remains an issue. That is why the 
association supports the Improving HOPE for Alzheimer's Act, 
which would help educate clinicians on Alzheimer's and dementia 
care planning services through Medicare.
    We are grateful to Senator Collins for her leadership on 
the legislation.
    Thank you for your time and for the invitation to be here 
with you today. I am happy to answer any questions.
    The Chairman. Thank you for your testimony.
    Dr. Fekrat.

               STATEMENT OF SHARON FEKRAT, M.D.,

            PROFESSOR OF OPHTHALMOLOGY AND ASSOCIATE

         PROFESSOR OF SURGERY, DUKE SCHOOL OF MEDICINE,

                     DURHAM, NORTH CAROLINA

    Dr. Fekrat. Thank you, Chairman Collins, Ranking Member 
Casey, and members of the Committee for the opportunity to 
testify and share some very exciting multidisciplinary and 
collaborative work on one of the most important health issues 
of our time, Alzheimer's disease, the societal and cost impact 
of which you are well aware.
    My name is Dr. Sharon Fekrat, and I am a retina surgeon at 
the Duke University School of Medicine.
    Alzheimer's disease is the leading cause of dementia 
worldwide, yet its early detection remains challenging. The 
high cost of MRI, the limited sensitivity and specificity of 
genetic and serum markers, and the invasiveness of PET imaging 
and spinal fluid sampling limit our ability to detect 
Alzheimer's early.
    Alzheimer's has a 20-year relatively asymptomatic period of 
neuropathogenesis, there is growing interest in identifying 
Alzheimer's at asymptomatic stages for earlier clinical trial 
intervention to ultimately identify medications to delay the 
onset of, prevent, or even reverse Alzheimer's. We need rapid, 
easily accessible, inexpensive, noninvasive, yet accurate, 
diagnostic techniques to screen for Alzheimer's.
    The task before us is not insurmountable. If a human being 
can walk on the moon or live in a Space Station, then we can 
find a means of diagnosing Alzheimer's earlier and subsequently 
identifying effective therapeutic interventions.
    This requires collaborative teamwork across disciplines and 
institutions, innovative critical thinking, and going out on a 
limb where the fruits are.
    Look at the eyes of the person next to you. You see the 
colored iris and dark circular pupil. Yet there is so much more 
there than meets the eye. Behind the pupil, there is the 
wallpaper lining the inside of the eyeball called the retina.
    The retina wallpaper is the film of the camera. It is nerve 
tissue and a direct extension of our brain. The retina shares 
many structural and functional similarities with the brain. 
Spinal fluid biomarkers for Alzheimer's such as tau and amyloid 
have been found in the vitreous gel behind the pupil, and 
levels correlate with cognitive test scores. Amyloid has also 
been detected and imaged in the retina.
    The neurodegenerative process in the brain also occurs in 
the retina with thinning of certain retinal layers. Changes in 
the retina and its small blood vessels may mirror, or even 
precede, detectable changes in the brain and its small blood 
vessels.
    Imaging the retina in Alzheimer's, however, is not new. 
Color photographs of the retina in Alzheimer's show decreased 
retinal vein diameters, blood vessel branching complexity, and 
tortuosity. Recent imaging advances now allow us to evaluate 
the retinal microvasculature with unprecedented detail on the 
order of 5 microns, not even the width of a human hair, using 
new technology called OCTA which takes almost 70,000 scans per 
second to look at the very small retinal blood vessels.
    With this FDA-approved imaging technology, we can now take 
pictures of the retina through an un-dilated pupil quickly, 
noninvasively, inexpensively, and reproducibly at high 
resolution.
    Several research groups, including our group at Duke, are 
exploring how this technology along with other retinal imaging 
methods can be used to diagnose preclinical Alzheimer's.
    We recently completed the largest prospective study using 
this technology, OCTA, of 70 eyes with Alzheimer's, 72 eyes 
with mild cognitive impairment, or MCI, and 254 eyes from 
cognitively healthy adults. We found decreased retinal blood 
vessel density and thickness in one of the retinal layers in 
Alzheimer's compared to MCI and compared to controls, even 
after adjusting for age, sex, and education.
    A larger sample size may be needed to detect the difference 
between MCI and controls because of the varied spectrum of MCI.
    Our study adds to the published literature and improves our 
understanding of the smallest blood vessels in Alzheimer's. 
Right now, these tests cannot be used to solely diagnose 
Alzheimer's, but this is the beginning of something big.
    Before these tests are ready for prime time, the findings 
must be validated in larger and diverse populations. The goal 
is to obtain multimodal retinal images that would result in a 
suite of biomarkers that could predict the risk of Alzheimer's 
and stratify the stages of disease, similar to getting a 
cholesterol panel and being able to determine your risk of 
heart disease.
    The potential impact on early detection and clinical trial 
results is motivating. We are building multidisciplinary and 
multi-institutional teams and forging relationships with 
industry to move forward. We are collecting longitudinal data 
to assess changes over time, imaging genetically predisposed 
asymptomatic persons, using images for artificial intelligence, 
and collecting retinal images globally to store in a central 
registry for researchers to access.
    Our eyes may indeed be windows to our brain health.
    Thank you for your efforts to support those working to find 
the way forward, which in turn supports those with Alzheimer's 
disease and their families. Time is of the essence.
    The Chairman. Thank you very much for sharing your 
research.
    Dr. Hodes, welcome back. We are delighted to have you join 
us again this year.

              STATEMENT OF RICHARD J. HODES, M.D.,

             DIRECTOR, NATIONAL INSTITUTE ON AGING,

       NATIONAL INSTITUTES OF HEALTH, BETHESDA, MARYLAND

    Dr. Hodes. Thank you, Chairman Collins and Ranking Member 
Casey and members of the Committee for the opportunity to be 
here and share the basis for the hope which we now have as a 
result of research through support that comes from you and 
looking forward toward research accomplishments, recent and 
future, and I will try to do justice to the scholarly 
introduction that Senator Collins provided of the research that 
is now ongoing.
    If we look at the next slide, just to illustrate the 
magnitude of increase and support that has come from 
congressional appropriations of around $600 million in 2016 
through what you see is a total of $1.9 million in 2018 and 
2019, the current year, if we add the appropriations and 
estimate the total, this would be approximately 2.3-to $2.4 
billion, an extraordinary increase.
    Importantly, it has energized and excited the research 
community. It has led to the recruitment of a large number of 
new investigators, people who are trying to tie the directions 
they would place their wisdom and their careers and now take it 
to the important cause of Alzheimer's research.
    It has led to the current support by NIA of approximately 
140 clinical studies and trials. Some of these are in the 
important area alluded to, trials to identify the most 
effective means of providing support, care, and services to 
those already affected. Others are a diverse set of trials 
looking at the strategies for prevention, cure, treatment of 
disease.
    Some number of those are non-pharmacologic, looking at 
interventions such as exercise, diet, cognitive training, or 
combinations of them.
    If we look at the next slide, an example of the number and 
diversity of pharmacologic studies undertaken, this illustrates 
here at various stages of drug discovery, drug development, 
then their implementation in early stage clinical trials, and 
finally, the more advanced stage III clinical trials, and the 
colors are intended here to show the number of trials attacking 
different categories of targets.
    Alluded to, was amyloid, which remains an important area of 
research where failures have occurred in attempts to treat at 
later stage of disease by targeting amyloid, where hope 
remains, and additional trials are targeted at looking at early 
intervention.
    Notably, as commented upon, the availability of biomarkers 
that now detect disease years to decades before symptoms means 
we can make a difference by targeting interventions not only of 
people who need them or had the disease but those for whom 
prevention is important before the onset of substantial damage 
to neurons and their connections within the brain.
    In the next slide, you see a summary of what we have just 
shown in color to make it simply evident that the numbers of 
trials targeting amyloid, in gray, is far exceeded by those, 
the diversity of targets that you see here, so if some 32 
trials are currently ongoing, only 13 are now targeted toward 
amyloid.
    The diversity comes from a variety of basic studies, new 
methods for identifying genetic, molecular underpinnings of the 
processes that occur in Alzheimer's, amyloid and other, are 
translated into new targets for intervention.
    Most recently, in public-private partnerships with pharma, 
biotech, academic institutions, in a new spirit of big data and 
open data, these findings, the large data, then computational 
analyses have led to the discovery of new potential targets 
recently published, a wall of targets, some 100 candidate, 
best-consensus candidates for future studies, which will now go 
into the pipeline in development for ultimate clinical trials, 
giving us hope and expectation with these multiple approaches 
that will do far better in making advances toward treatment, 
cure, and prevention.
    In the next slide, this is just an illustration of the pace 
of advance in one of the areas of basic science. This is in 
genomics. If you look at the discovery of genes, which are 
associated with either a higher risk of Alzheimer's or a lower 
risk, that is, protective factors, you can see year by year, 
the increase in number of genes there.
    Just to note, in 2018, that large list of genes is more 
than has been discovered, had been discovered in all the 
preceding years. They are color-coded here, hard to see, I 
know, but meant to illustrate that the genes are not random but 
fall into patterns which give us ideas of the targets--vascular 
and areas of protein transport and inflammatory pathways--and 
each and every one of these discoveries, again, gives us a new 
clue in terms of directions to take for cure and prevention.
    Finally, in the next slide, it just illustrates, once 
again, the importance of providing research, evidence-based, 
identification of the best strategies for care and caregiving 
for those who are affected with disease. Just as we hold 
summits bringing together the best science for cure and 
prevention, we do the same in the area of care and caregiving, 
and this will continue.
    The first prize under the 21st Century Cures authorized is 
in fact a prize to identify an app to help in navigating the 
often complex and challenging situation for those who are 
looking to find a way through the resources available and those 
lacking as they pursue care and caregiving.
    With all of this, with the inspiration we have from the 
appropriations from you, the inspirations of those here in the 
room, the hope provided by the cadre of investigators now 
studying disease, the courage shown by those who participate in 
clinical trials, with all of this we reinforce the hope we have 
for a future that will take us toward an end of Alzheimer's 
disease.
    Thank you.
    The Chairman. Thank you very much for that hopeful 
testimony.
    Mrs. Hartt, I am going to start with you. You talked about 
the difficulty that you and Mike had in obtaining an accurate 
diagnosis. That is one of the reasons I am so interested in the 
research that Dr. Fekrat is doing, which might make that much 
easier for you.
    Initially, you knew something was wrong, and Mike underwent 
a series of tests. You got a diagnosis that was not correct 
originally, and I am curious how knowing the accurate diagnosis 
helped you both cope with the disease.
    Mrs. Hartt. Knowing the accurate diagnosis helped us cope 
by being able to make a plan. We were at that point able to 
digest that this is what was going to be, and as I said, we 
simplified our life. We began to say what can Mike do, and we 
just came together about what did he want to do, what could he 
do.
    I got my job that I have always loved. I kind of started 
working less, and then I retired, which is a big move to do, 
and when I was sitting on the beach this winter, I began to 
wonder why am I missing my job, but, you know--but we have been 
absolutely taking the approach of saying today is a great day, 
and we are going to enjoy it.
    The Chairman. That is a great attitude to have.
    Mike, what was the most difficult decision that you had to 
make once you received your diagnosis?
    Mr. Hartt. I never was one to look for help from anybody. I 
always found my own way, and it is hard to depend on somebody 
else.
    The Chairman. I think that is very true, and I appreciate 
you sharing that with us.
    Dr. Hodes, we know now that Alzheimer's disease has proven 
to be far more complex than we had hoped, and research teams 
around the country and the world are working to better 
understand this disease.
    The Alzheimer's disease Precision Models Center is one such 
cross-country partnership, and through this center, I am proud 
to say that scientists at Jackson Laboratories in Bar Harbor, 
Maine, are developing mouse models for Alzheimer's, and data 
are shared with the Indiana University for clinical use and 
also with Sage Bionetworks in Seattle for public use.
    This data sharing, I think is so important. Particularly if 
the Federal Government is funding these projects, it seems to 
me that the more data sharing the better, so what specifically 
is NIH doing to foster that kind of collaboration and data 
sharing that could help us advance the research?
    Dr. Hodes. Thank you very much for asking about this very 
important aspect, and I am proud, happy, excited to say that 
the culture around Alzheimer's research in particular has been 
a model in terms of the appreciation for the need for data 
sharing.
    Large and larger datasets, rather than being hoarded, 
guarded, and reported by individual laboratories, are now being 
analyzed with increasing power due to the numbers of these data 
and an open analysis for all of those who want to lend their 
wisdom to it.
    NIH in fact now has a policy that insists upon sharing as a 
condition of award. We monitor it carefully, but I am again 
most pleased to say this has become a part of the spirit of 
science, and it is consistent with our regulations but requires 
very little push. I think science has come to realize that all 
researchers--public gain by an optimization of a sharing of 
data toward common goal.
    The Chairman. Thank you.
    Let me followup also by asking you--the last time you 
testified you said that we did not know how to present the 
disease, and I know if there were a pill that we could take to 
promote brain health that every one of us would want it. Has 
there been any progress since the last time you testified on 
the prevention side?
    Dr. Hodes. Yes. Thank you again for the question.
    The study referred to, last reported, was an exhaustive 
review of the literature carried out by the National Academies 
of Science, Engineering and Medicine, which found that there 
was encouraging but no inclusive evidence for interventions 
that would significantly slow cognitive decline or decrease the 
risk of dementia.
    Since that time, there was a great deal of excitement about 
the report, of a study, SPRINT and SPRINT MIND. Now, the SPRINT 
trial was going to see the effect of reducing blood pressure to 
140, which had been a previous target, or 120, a more 
aggressive target for controlling blood pressure.
    The trial itself was stopped prematurely for ethical 
reasons because of the more aggressive decrease in blood 
pressure had impact on survival, on cardiovascular disease, but 
we had initiated in concert with that study monitoring of brain 
imaging, of cognitive function, and we are pleased to see the 
interpretation released just a few months ago that the more 
aggressive control of blood pressure was associated with a 
significant decrease in mild cognitive impairment, an often 
precursor of dementia.
    These studies will continue, but they now for the first 
time identify a specific intervention, evidence based in a 
randomized control trial, for something that can prevent 
cognitive decline often associated as a precursor of dementia.
    The Chairman. That is good news. Thank you.
    Senator Casey. Thank you, Chairman Collins.
    We all know that our aging population is growing a lot more 
diverse, and as I mentioned in my opening statement, the rate 
of dementia among both African Americans and Latino Americans 
is already high and actually on the rise.
    Both groups are severely underrepresented in research and 
in clinical trials, and many in these communities lack access 
to high-quality diagnostic treatment and support services.
    I will start with Clay Jacobs for this question. Clay, you 
mentioned in your testimony, you made reference to volunteers 
that the association recruits to reach out to these underserved 
populations. Could you provide details on two things? One is 
who these volunteers are, and I know you have provided some in 
your opening.
    The second part of it is if you could provide information 
about the importance of educating people about their options 
for enrolling in clinical trials.
    Mr. Jacobs. Thank you for the question, Senator.
    To reach members of underrepresented and underserved 
communities, the Alzheimer's Association has launched several 
recent initiatives that resulted from input and feedback from 
people in those very communities. We are recruiting volunteers 
to engage with faith and Spanish-speaking communities. The 
association has partnered with the Mexican Consulate to engage 
in the Hispanic and Latino communities with information on 
Alzheimer's detection, diagnosis, care, treatment, research, 
and access to culturally appropriate resources.
    In collaboration with the National Hispanic Council on 
Aging, we are building a network of ``promotores,'' or 
community health workers, who deliver Alzheimer's education in 
Latino communities and help connect people to resources and 
services in Spanish.
    With regard to clinical trial recruitment, it is critical 
that we are aggressive in pursuing a therapy since Alzheimer's 
is one in the top ten causes of death without a proven way to 
prevent, treat, or slow progression. Therefore, we must have 
robust clinical trial participation.
    In Pennsylvania, the Delaware Valley Chapter is a member of 
the University of Pennsylvania's African American Family 
Advisory Council to help guide their efforts and provide 
feedback on increasing diverse participation in clinical trial 
enrollment.
    Another great example is in Pittsburgh with the Alzheimer's 
Disease Research Center. We offer support groups, community 
education events, community research presentations, and more 
things based in communities to try and increase clinical trial 
recruitment and overall engagement with the community, but with 
a specific focus on African Americans in southwestern 
Pennsylvania.
    The Chairman. Thanks very much.
    Dr. Hodes, I am going to turn to you as well, as Senator 
Collins did. She has referred to 200,000 people having younger 
onset Alzheimer's disease. That is where we have the bill, the 
Younger-Onset Alzheimer's Disease Act, that we are working on 
together to ensure that this population can receive the 
supportive services through a vast network of programs funded 
by the Older Americans Act.
    As I mentioned in my opening, I am also concerned about the 
overlap here of people with disabilities, specifically those 
with down Syndrome, who are diagnosed with Alzheimer's disease 
at younger ages.
    Can you share with the Committee how researchers are 
working to include people with disabilities in research related 
to both Alzheimer's disease and also related dementias?
    Dr. Hodes. Certainly, Senator.
    First, to touch upon the emphasis you placed on early onset 
Alzheimer's, an important area--and there is in fact now a 
LOADs, a longitudinal study for analysis of early onset 
Alzheimer's disease, that is designed to do just as you 
described. I understand those people, the burdens they face, 
also the potential for underlying differences in the biology of 
early onset disease. That study began last year and is accruing 
patients now.
    In terms of Down Syndrome, we have, together with the 
National Institute of Child Health, been working for some years 
to try to understand the high risk of Alzheimer's-like dementia 
alluded to in individuals with Down Syndrome.
    There has been now ongoing a longitudinal study which takes 
people that range from childhood into adulthood to look over 
time at the progression of cognitive function, of biomarkers, 
imaging and other to try to understand the nature of the 
progression of disease that occurs in these individuals, both 
to help people with Down Syndrome, but also in the spirit of 
informing all of us about Alzheimer's at large. It has been an 
exciting and inspiring community to work with, and we look 
forward to furthering and expanding that effort.
    Senator Casey. Thank you, Doctor. Chairman Collins, I am 
going to be jumping to a hearing, but I will come back, so, if 
we have a second round, I will have some more questions. Thank 
you.
    The Chairman. Thank you.
    I want to explain to our audience that we recognize members 
in the order that they come and then alternate sides, although 
on this disease, there is no side. It is a joint effort.
    Senator Braun is next.
    Senator Braun. Thank you, Madam Chair.
    This question is for Dr. Hodes, and it is going to be 
related to the FDA.
    This malady and many others, it seems like it takes so long 
to get through the approval process, and as illusive and vexing 
as progress has been, I would like your comments on things like 
mid-stage clinical trials and approval. In general, do you 
think that we need to look at some reforms to get things more 
quickly through the approval process, where you err a little 
bit on the side of giving the benefit of the doubt to getting 
these things to market more quickly as opposed to what seems to 
me to be kind of a laborious process that is overregulated and 
maybe counterproductive to getting to the finish line? A 
comment on that and any reforms in general as it would relate 
to the FDA involvement in Alzheimer's drugs.
    Dr. Hodes. Well, Senator, I would reflect that our own 
interactions with the FDA have found them to be very collegial, 
collaborative, and open in concept to the idea that endpoints 
for clinical trials and Alzheimer's in particular, the long-
term disease with the slow rate of progression or symptoms, 
could be based on progression and change in rate of progression 
of surrogate or biomarkers if they could be clearly defined as 
reflections of the pace of disease, so these conversations are 
ongoing.
    I should say in many of our initiatives, those looking at 
biomarkers and translation, it has been a constant to have 
presence of FDA involved, very much important, I think both for 
the academics but also for our pharma and biotech partners, who 
appreciate the fact that FDA is there listening and willing to 
be convinced by the evidence based to make decisions that will 
facilitate the most expeditious and yet responsible for 
qualifying of drugs.
    Senator Braun. It sounds like the congeniality has been 
there. Are you okay with the process? Do you have any comments 
on reforming it, even though they are interactive and 
interested, and do you think that in the case of Alzheimer's, 
should they be more aggressive on trying to advance stuff to 
the marketplace? Are you comfortable with the speed at which it 
is going?
    Dr. Hodes. I can say at present, yes.
    Senator Braun. Okay.
    Then I am looking at the resources, and we have gone from 
$631 million in 2015 to $2.3 billion in 2019. That is 
aggressive, and in this case, should it be more aggressive? 
When it comes to the funding, is the research and what is 
happening out there keeping pace with the availability of 
funding, and do you think that is about right or needs to be 
more aggressive?
    Dr. Hodes. Well, I think we have been fortunate in having 
the opportunity, in fact, requirement, to generate each year a 
so-called bypass or professional judgment budget. That is a 
budget that goes straight to you in Congress without 
modification by the Department or elsewhere in the 
administration.
    We take that very seriously, and from the beginning of the 
increase in funding and appropriations, we have each year 
examined--in the context of recommendations made by scientists 
at summits on a yearly basis, we find priorities, milestones 
for achieving those, and each year, in a very explicit way, we 
make the best professional judgment of what it would take to 
achieve each milestone, and so buildup, in a real sustainable 
methodology, our estimate for the needs in the following year.
    Each year, last year most recently--now in July, the next 
to be released--is our real professional judgment to you of 
what we think is required to optimally advance the cause with 
no consideration about limitations in funding and pleased to 
say that those estimates have been reflected in very real and 
appropriate proportion by the appropriations that follow. I 
therefore think we have a good match between scientific 
opportunity and appropriations and resources.
    Senator Braun. That is good to hear. Thank you.
    I yield the rest of my time.
    The Chairman. Thank you, Senator.
    Senator Jones. Thank you, Madam Chairman, and thank you for 
holding this hearing. I only hope that during my time in the 
Senate, I can become as strong an advocate for this issue as 
you have been over the years.
    Also, just for your benefit and the folks out there, 
Senator Collins also every year when we have these hearings 
does an incredible job of diverting the attention of the fire 
marshals so that we can get as many people in here as possible.
    Dr. Hodes, I would like to kind of followup a little bit on 
what Senator Braun was talking about.
    Seven years ago, the Country established a national plan to 
address Alzheimer's disease, which set a goal of preventing and 
effectively treating Alzheimer's by 2025. We are 6 years away 
from that date, and recognizing the many challenges that are 
associated with the developing therapies for Alzheimer's, I 
would like to just get your assessment of how we are doing, how 
far we are a progressing. Are we on track? Are there course 
corrections that we need to make, things that we can do to make 
sure that those goals are achieved?
    Dr. Hodes. Well, the goal for achieving significant, 
effective treatment by 2025 is a noble and important and 
aspirational goal, and it drives us constantly.
    We do not know precisely what the year will be by which we 
will achieve those.
    In terms of course correction, there is a constant 
modification and redirection. As I mentioned, each year we 
consult with experts. We reevaluate the progress made on goals. 
We identify whether there are new gaps, new science that needs 
to be sustained based on most recent discovery, so we are 
constantly renewing the strategies to optimize our chance of 
getting there.
    Whether it is in 2025 or as soon thereafter as possible, 
our goal is simple and shared with all of you to absolutely, as 
soon as it is humanly possible, given the resources provided, 
to make a different.
    Senator Jones. You are comfortable with where we are on 
track, though? Is there something else that we need to be 
looking at or focused on to make sure we stay on that track?
    Dr. Hodes. I think each year, we bring experts together to 
assure that we are up to date with the right input and making 
best judgments.
    I am not satisfied--none of us are satisfied--given our 
failure as yet to achieve effective interventions, but I think 
we are on the right track with information to constantly update 
and optimize our strategy for getting there.
    Senator Jones. Great. Thank you.
    This could really go to any number of folks here, I guess. 
We have got several major medical research facilities across 
Alabama that I think are making tremendous contributions to the 
understanding and treatment of Alzheimer's, but the problem is 
sometimes Alabamans live hundreds of miles away from these 
facilities, and I think that there is some disparity with not 
just the underserved areas, Mr. Jacobs, that you talked about, 
but the rural area that populations seem to be affected even 
more.
    What can we do to make sure in these clinical trials that 
folks in these rural areas also have the availability and the 
ability to participate in some of these clinical trials?
    I will open that to Mr. Jacobs or any one of the panelists.
    Mr. Jacobs. Thank you, Senator. Thank you for the question.
    I think as I look at this, 70 percent of Pennsylvania's 
counties are considered rural, which can often pose challenges 
to receiving a diagnosis, accessing services, transportation 
and more, because of this, at least in our Commonwealth, what 
we have tried to do is approach where people go for services 
and where they ask.
    A great example is actually Geisinger Health System that 
received part of a Federal grant, but as part of the trial, we 
are proud to work with them on the care and support side, how 
do we convene stakeholders, how do we make sure that we are 
contributing to project design and people living with the 
disease are represented, that we are providing materials to 
share after diagnosis, so that when people do connect, they 
know there when to turn.
    Even in that instance, many of those participants are being 
directly referred to us, and so from these association in 
Pennsylvania, what I would say is one of the things we are 
trying to do is make sure we are connecting to communities, 
whatever people consider them, the systems where they go, and 
just trying to make sure whatever door folks enter that they 
are receiving the best possible care and support, and we go 
from there.
    Senator Jones. Great. Thank you.
    Yes, ma'am.
    Dr. Fekrat. I think also making some clinical trial sites 
at VA medical centers and their CBOCs and outlying clinics can 
also help recruit a wide variety of patients and a diverse 
population.
    The VA offers transportation for the veteran patients and 
may make it easier to improve the diversity.
    Senator Jones. Great.
    Well, thank you. Thank you all for being here today, your 
testimony, and thank you all for coming and sharing your 
experiences. Thank you.
    The Chairman. Thank you, Senator.
    Senator McSally. Thank you, Madam Chair.
    Thank you to everybody for being here today and the 
wonderful group of advocates as well in the room on this really 
important issue.
    I represent Arizona. It was reported last month that 
Arizona has the fastest growing rate of Alzheimer's in the 
country. Of the 5.8 million estimated Americans, 65 and over, 
impacted, 140,00 are in my home State.
    Furthermore, the death rate in Arizona is almost 20 percent 
higher than the U.S. average, so this is something that is very 
real for the people that I represent.
    Mary and Mike, thank you for being here and for your 
testimony. It was very moving, and for those who are behind you 
could not see. As Mary was testifying, Mike was choking up 
several times, and it was very tender to just see the 
connection that you have and the support that you have with one 
another.
    Many aging Americans and many Arizonans that have 
Alzheimer's do not have that support. They are aging alone, and 
they are dealing with this disease alone. I cannot even imagine 
navigating what you are navigating without someone like you, 
Mary.
    Mike, this may be a hard question to ask, what would you do 
if you did not have someone like Mary as you are navigating 
this disease?
    Mr. Hartt. I would make the best of it, and that is a hard 
thing to say. I take every day as it comes. It is just an 
adventure.
    Senator McSally. God bless you, Mike, really for being here 
and for being willing to share your personal story for others.
    Our local paper in Tucson shared stories like yours in a 
series last year. I think it was really helpful for people to 
hear the real challenges, the inspiration, just understanding 
from other stories, the opportunities there are for help from 
the community as people are struggling with Alzheimer's.
    Mary, as a caregiver, this is really challenging. One story 
we had in this series was of a woman named Joan in Tucson, a 
local church pianist, a choir director for 35 years, and her 
husband, Clark, who was a caregiver for 13 years alone, and he 
then suffered with depression and other things.
    Can you share a little more about what helps you as a 
caregiver to be fully present and able to support Mike while 
also caring for yourself?
    Mrs. Hartt. One of the major benefits initially was that I 
got in a younger-onset support group. They were other people 
who had been down the road before me. Many of them were further 
along with the disease than myself. I was able to look at where 
we were sort of in a lucky place because we were not there yet.
    I run. I look at my running as something that takes an hour 
or so a day to do. Mike is fine to be alone. It is a stress 
breaker for me. I am outside. I am feeling the sunshine, that 
aspect of things, and then maybe I find a little joy being 
Mike's camp counselor. He might groan at this.
    I come up with a plan pretty much every day to say, ``Okay. 
Today we are going to''--and so we try not to be in the just 
sitting at home. We are always trying to find something because 
for nothing else--and when we are in Bangor to go to City 
Forest and have a picnic. It is not like it is expensive stuff. 
It is just doing something.
    Senator McSally. Great. Thank you.
    I am a runner too. I totally get what you are talking 
about. I appreciate it.
    Clay, can you share other resources that are available to 
caregivers like Mary, so that they are not alone, and they can 
access support from others?
    Mr. Jacobs. Absolutely. Thank you, Senator, for that 
question.
    I think as we look at it, early stage and younger-onset 
support groups are key. Social engagement programs throughout 
our chapter network nationwide are available. Even something as 
simple as our 24/7 help line, so folks can know when they are 
interested and able and willing to reach out that there is 
someone who will be there to answer, be able to talk with them, 
be able to support the next steps in that. That is a privilege.
    The association and my colleagues are volunteers. We get to 
provide and be able to connect with such fantastic people like 
the Hartts.
    Senator McSally. Great. Thank you. I appreciate it.
    Thank you, Madam Chair.
    The Chairman. Thank you, Senator.
    Senator Rosen. Thank you so much, Madam Chair. I really 
appreciate you bringing this forward.
    I appreciate all of you being here. It is an incredibly 
important topic. We had one of our constituents, Chuck, you saw 
in the video. We thank him for being such a great advocate.
    What I want to say is this really hits particularly close 
to home for me because I stepped away from my career to take 
care of my aging parents and in-laws, and at the end of my 
mother-in-law's life, she suffered from Alzheimer's, lived in a 
memory care unit, so I went through this personal journey, 
myself along with some of my friends that I met along the way, 
and I know the toll that it takes on families.
    For me, as I think back on what I went through, I think 
coordinated care is really a big part of the key. I was going 
to so many different doctors, and it seemed like I did not have 
that centralized care.
    How do you think we should think perhaps about coordinated 
care for a patient, and who do you think the best person would 
be in the team of caregivers to coordinate this?
    Doctor, do you have a----
    Dr. Hodes. It is a great and important question. As I 
alluded to, research, to try to provide evidence for the best 
strategies for providing care and services is a very active 
part now of the trials we carry out, and there is not going to 
be a simple answer and the same answer for all populations. It 
may be different for urban and rural populations, for different 
ethnic and racial groups.
    Senator Rosen. Even managing the amount of medications that 
an older person takes that can often interact, sometimes you 
are going to so many different physicians, you can have side 
effects based on those things too.
    Dr. Hodes. Absolutely. I think, as you are alluding to 
quite rightly, it does require a team of individuals with 
varied expertise, but just how to orchestrate those, organize 
those and make those accessible to all who need them, is itself 
a subject of active research, so we are looking at ways in 
which now, for example, with a collaboratory that will put 
together clinical trials designed to see what use of health 
care systems can best coordinate care, and we will soon be 
issuing a solicitation for applications from academics and 
consortia to try to search for the beset combinations.
    I mentioned there is a prize, the first price under 21st 
Century Cures that has been issued by NIA, which asks for apps 
that may help to navigate through the multiple steps, some of 
which you have enumerated, people need to understand in order 
to coordinate care.
    It will be different for people living alone, those who 
live in communities, and we are trying to target each of these 
situations with understanding and sensitivity.
    Senator Rosen. I look forward to us having that hearing 
here because I think for me as I went through that journey--of 
course, four different journeys with my parents and my in-laws, 
each person different--understanding how you coordinate care 
and collaborate for the caregiver is extremely important.
    I want to move on and ask one more question about medical 
data collection. It is critical to all research, particularly 
Alzheimer's and so many diseases, so what I want to ask is 
this. How many years has the NIH been collecting data on 
Alzheimer's disease, and what picture does this aggregate data 
show us about the disease and where we are headed in the 
future?
    Dr. Hodes. NIH, NIA have been collecting longitudinal data, 
including Alzheimer's disease, for decades now.
    Now, the data have emerged, have evolved from a time in 
which they were simply reported of diagnosis to a point in 
which cognitive testing, biomarkers have become a part of it, 
and over the last 10 and 20 years, there has been more and more 
of this. I think there is now a great effort going into how to 
best use electronic health care records together with 
administrative records like Medicare, Medicaid, to put all 
those together with clinical trials data to maximize what we 
learn from information about any one individual.
    Senator Rosen. Let me ask you. What do you think are the 
gaps in what you are collecting? So how can we help you fill 
those gaps? Because I know the data tells a story. Those 
predictive analytics helps your research, helps all of us, so 
what gaps do you think we need to fill in getting you the right 
aggregate data?
    Dr. Hodes. I think we need to continue our efforts to work 
very closely with those who have data of relevance. The medical 
care systems and electronic health records, Medicare and 
Medicaid data, experimental longitudinal studies supported by 
the Federal Government, in each of these there are 
considerations of privacy, of confidentiality that we have to 
accommodate to, nonetheless, being able to share data across.
    I think we have made progress. We now have through enclaves 
in which confidentiality is assured. The access is limited to 
specific questions. We can bring together data from these 
several sources, analyze them, and then let the confidentiality 
remain for individual studies.
    We are learning with the power of computational biology 
more and more. We certainly have not reached an optimal stage 
yet, but continued progress, I would say, in bringing together 
these various sorts of data.
    Senator Rosen. Thank you. Appreciate it.
    The Chairman. Thank you very much.
    Senator Hawley. Thank you, Madam Chair. Thank you for 
convening this very important hearing.
    I want to start by saying I represent the great State of 
Missouri, and there are over 20 Missouri advocates who are here 
in the room with us today. Thank you so much for being here. 
That makes me very proud.
    One of those advocates is Lonni Schicker, and I just want 
to share just a small piece of her story that I know will 
resonate with all of you.
    Lonni came to the Alzheimer's Association at the age of 59 
when she had a test that revealed she was suffering from mild 
cognitive impairment. That diagnosis placed her at higher risk 
for dementia, and since then, she has been diagnosed with 
Alzheimer's.
    Let me just read to you what Lonni said. She said, 
``Because I am younger, I am the younger face of this disease. 
I had to stop working as a professor, and since Missouri does 
not have resources as robust as other States, it has made it 
very difficult for my family and I to access support and 
services. It took me almost 3 years to get a diagnosis because 
doctors were hesitant due to my age.''
    This is so true what Lonni faces, what so many folks around 
the country face, and I just want to say, Lonni, thank you for 
being here, and thank you for being so courageous to share your 
story.
    This is something that is also personal to me as it is, I 
suspect, to almost every family in America. My family too has 
struggled with Alzheimer's. My grandparents, my uncle have 
struggled with this disease.
    In my State, in 2017, over 2,500 people died from 
Alzheimer's. We currently have over 5,000 in hospice care who 
suffer from Alzheimer's or an associated form of dementia, so 
this is a serious, serious problem in my State.
    I want to ask Mr. Jacobs, if I could. Your testimony, I was 
particularly struck by. Coming from a rural State like 
Missouri, your discussion about programming in rural areas, 
Senator Jones became to touch on some of this. I just want to 
come back to it.
    Can you elaborate for us the challenges that you have found 
in serving rural communities, outreach to those communities, 
and any strategies that you have found that are successful for 
expanding services into those areas?
    Mr. Jacobs. Absolutely. Thank you, Senator.
    As we look at it in Pennsylvania, one of the greatest 
challenges is being clear on what the concerns are. Every 
community is different, and so I think that highlights for me 
one of the strategies that we have taken that we have proven to 
be successful is not assuming we know what is best or what 
services will be the best fit for that community, and so what 
does it look like to be able to convene leaders in that 
community, whether it is the mayor's office and business, 
people impacted by the disease and others, to hear from them 
about what challenges they are facing, to be able to work 
together on how do we resolve that.
    These type of community forums are incredibly valuable to 
make sure that we are spending time on things that are 
impactful, but that we are doing it with an ear to what really 
matters to folks who live there, who are invested in, and that 
we use that as a way to not only engage the community but 
really mobilize the community to support each other and to be 
able to work together, so that is one of the greatest examples 
that I think can be replicated throughout the U.S., and we know 
we have seen results in Pennsylvania.
    Senator Hawley. Can I just ask you on that point in terms 
of mobilizing folks in the community? You also mentioned 
several times in your written testimony, your work with faith-
based groups and outreach to faith-based groups. What role does 
working with that community play?
    I am thinking of where--I come from a very small town in 
Missouri. I am from rural Missouri. My town, Lexington, 
Missouri, has fewer than 5,000 people, and of course, 
communities across Missouri, rural communities, have faced 
hospital closures, the loss of clinics, but often there is a 
robust faith community in these areas.
    What have you found in working with faith-based communities 
and faith-based outreach? How has that worked? Has it been 
helpful? What has been successful? What not?
    Mr. Jacobs. Absolutely. We have mentioned communities a few 
times, and I think for me and I think others, community is 
whatever you associate with it. It may be geography. It may be 
family, your workplace or others. It is where you turn, and for 
many, that is the faith community.
    For us to effectively engage people, if you are concerned 
about memory or you have noticed symptoms or you have noticed 
it in others, often it may be a church group. It may be your 
pastor. It may be others we are turning to, so how do we 
effectively engage so that that is a way to continue the 
conversation? So it really is about identifying there and where 
people turn. What does it look like in the AME church to know 
that there is connections and to have those relationships?
    One of the things we hope to do is to be able to be a 
convener and a connector, and if we can start that conversation 
and give that platform, how meaningful it will be for folks who 
maybe turned previously and did not find that support.
    Senator Hawley. Richard, did you want to add something 
here?
    Dr. Hodes. I do not want to fail to emphasize that with NIH 
and the Federal Government, its role in trying to engage, in 
acquiring evidence for the best ways to diagnose, treat, and 
manage, the partnerships you have been hearing about are very 
much a part of what we do.
    The Alzheimer's Association here and the National Institute 
on Aging have a hugely effective partnership that then involves 
the faith-based groups, community associations.
    I could not agree more that for us to carry out research 
that engages a diverse population, we have to deal with the 
institutions where those individuals live. The Alzheimer's 
Association has been often a great means of connecting with 
those communities. It is a partnership between Federal 
Government and communities that is invaluable in this effort.
    Senator Hawley. Thank you.
    Thanks to all the witnesses for being here and for your 
outstanding work. Thank you for sharing your personal stories, 
and thank you for the advocates, for being here and for 
advocating for folks who are going through this and who are 
hoping for progress and a cure. Thank you for being willing to 
share your stories.
    Thank you, Madam Chair.
    The Chairman. Thank you, Senator.
    Senator Sinema. Thank you so much to our Chairman and to 
our Vice Chair for today's hearing on Alzheimer's.
    This is an especially critical topic for my State, Arizona, 
which as you know has one of the highest rates of Alzheimer's 
in the Nation.
    It is also quite personal for me, as my grandmother 
currently suffers from Alzheimer's, and my aunt is her full-
time caregiver. I thank all of our advocates for being here 
today, and I give my special thanks and my special welcome to 
those who are living with Alzheimer's and those who are caring 
for family members with Alzheimer's.
    Right now, over 140,000 Arizonans over the age of 65 life 
with Alzheimer's, and that number is expected to increase by 43 
percent in Arizona by 2025, so that is why the city of Tempe is 
leading the way to help address the toll that Alzheimer's has 
on patients and caregivers.
    Our mayor of Tempe, Mark Mitchell, knows this firsthand. 
His mother Mary Ann has been living with Alzheimer's for over a 
decade. Mark's father, former mayor of Tempe and former 
Congressman Harry Mitchell, has devoted himself to caregiving, 
but their family saw the impact that Alzheimer's was having on 
both Mary Ann, who required progressively increased levels of 
care, and on Harry as her primary caregiver, so it was Mayor--
Mark decided to do more, so he partnered with the Banner 
Alzheimer's Institute, and it has made Tempe into the Nation's 
first Alzheimer's-and dementia-friendly city, so with the goal 
of creating a safe and livable community for people living with 
dementia, Tempe has trained thousands of volunteers and first 
responders to recognize and respond to dementia sufferers in 
the community, and the city also hosts every Monday a Memory 
Caf? to provide patients and caregivers a place to socialize 
and find comfort and support.
    The message that Tempe is sending to Alzheimer's patients 
and their loved ones is that they are not alone, but of course, 
we all know and as we have heard here today, we can and must do 
more.
    I wanted to start with asking you a question, Dr. Hodes. 
Your testimony mentioned a recent study from the National 
Institute on Aging that found in the last 5 years of life, 
total health care spending for people with dementia is more 
than a quarter million dollars per person, so does that figure 
include the cost that family caregivers bear by losing wages, 
the lost impact on Social Security benefits, and the cost that 
occurs to their own health?
    As you probably know, in the State of Arizona, we have 
nearly 340,000 caregivers who provide more than $4.8 billion of 
unpaid care a year. If you could share a little bit more about 
your numbers and what they include, that would be helpful.
    Dr. Hodes. Yes. Thank you.
    The costs by disease have been compared in a series of 
reports lately and as alluded to here. Alzheimer's disease is 
really the most expensive disease, in particular, in the last 
years of life.
    In those calculations, it has been important in the studies 
that it be done--and I think has been well done--to include 
both direct costs, out-of-pocket, Federal, but the indirect 
costs, the loss of wages, the value of the care being provided, 
so the total numbers, as huge as they are that you report, are 
attempted in the studies we carry out to account for all of the 
varieties of cost, direct, indirect, that you mention.
    Senator Sinema. Thank you.
    Research has shown that early biomarker evidence of 
Alzheimer's can be detected through PET scans and even when 
someone maybe shows little or no clinical symptoms, so given 
that we now know that early diagnosis helps patients benefit 
from treatment, clinical trials, and allows families to create 
a care plan, my question for other members of the panel is, 
what types of questions should family know to ask their doctor 
early on if they are concerned that their loved one may be 
subject or have a predisposition toward Alzheimer's?
    It looks like it is you, Mr. Jacobs.
    Mr. Jacobs. Thank you.
    I think really what I could best touch on is, anecdotally, 
as we hear from families. It is the willingness to have that 
conversation with each other, the willingness to be able to 
engage physicians and others, because we know that often the 
disease, diagnosis is not disclosed.
    We know through the Alzheimer's Association's recent Facts 
and Figures Report that while 82 percent of seniors think 
cognitive assessment is important, only 16 percent report 
regularly receiving them.
    This conversation needs to shift, our comfort with it, and 
what I think had traditionally been a disease that we talk 
about quietly, today, as a great example with this hearing, 
with all of the folks who are behind me in this room and across 
the Capitol, it is that the urgency, the need, the passion, and 
the volume is raised, so we need to take that back to our 
communities and continue the conversation and be willing to 
talk with each other when we notice symptoms, be able to walk 
with our providers, and I think that is just a key point to 
start as we look at moving forward.
    Senator Sinema. Thank you so much.
    Chairman, I just want to take a moment to thank all of he 
advocates who are here, not just here in this room with us 
today, but all over the Capitol sharing their stories of 
personal experience with Alzheimer's, and I want to thank you 
for taking the time out of your life to do that and to share 
these highly personal stories and let you know they do make an 
impact.
    Thank you.
    The Chairman. Thank you, Senator.
    Dr. Fekrat, your research points to a whole new direction 
in our understanding of Alzheimer's disease, and I find it very 
exciting that you are exploring the link between vision and 
cognitive health.
    Could you tell us how you decided to study that potential 
ink?
    Dr. Fekrat. Well, our group specifically became interested 
in joining the other researchers around the world that are 
studying this link. After we were examining a set of identical 
twins in our clinic in the middle of a busy day, one set of 96-
year-old identical twins with the same DNA and genetic risk, 
however, one had advanced Alzheimer's disease and the other one 
was cognitively healthy, living independently, using a 
smartphone, talking about current events.
    We took this opportunity to take this new technology that I 
had mentioned, OCTA, and obtain images in both of the twins, 
and we saw a striking decreased retinal vessel density in the 
twin with advanced Alzheimer's, so this showed us that 
independent of aging that Alzheimer's had the decreased retinal 
vessel density, and that sort of spurred the rest of our work.
    The Chairman. That is absolutely fascinating.
    Dr. Hodes, one of the reasons that I am so excited by the 
charts that you have placed and explained is that we have 
concentrated the research on amyloid plaque, on tau, and yet, 
as you pointed out when you talked about blood pressure, it may 
be that cardiovascular factors are at play, which seems to be 
what our ophthalmologist has just discussed as well.
    Has the expansion in funding allowed you to fund 
applications for grant money that are exploring whole new, 
different, out-of-the-box areas that we have not previously 
looked at?
    Dr. Hodes. The answer is absolutely yes in a most exciting 
way.
    Just a couple of examples, in the studies of the genetics 
and gene expression patterns that I mentioned, over hundreds 
and thousands of brains looking for generic targets that were 
previously unanticipated, one, I would say, intriguing 
provocative report published last year found changes that were 
associated with viral infections of a type. This is another 
dimension to what has been raised over the years, the 
possibility that there might be infectious and inflammatory 
components.
    Another example, as we look at the impact of what we would 
call normal aging, changes that occur with aging and how they 
interact with Alzheimer's, why does Alzheimer's disease occur 
in later years of life generally, among the changes that occur 
with aging at a molecular, cellular level, we are just 
discovering, is something called ``cellular senescence.'' In 
each of us, in all our organs and tissues, as we age, a number 
of cells become senescent. They do not divide the way they 
normally do. They have a different phenotype or type . They 
secrete inflammatory molecules, and what has been found in some 
very interesting studies, even in animal models, you find very 
clever genetic or pharmacological ways to get rid of those 
senescent cells called ``senolytics.'' You are lysing the 
senescent cells. It actually has a positive impact in the brain 
of a mouse model of Alzheimer's disease in terms of decreasing 
damage, in fact, even allowing reversing of damage, examples of 
very disparate ways in which research is carried out by people 
in a totally different field are now being drawn into the area 
of Alzheimer's research.
    As one strategy for doing it, we recently in this past year 
looked at all of the institutes across NIH and asked whether 
their investigators who were not studying Alzheimer's research 
had proposals to extend their expertise into Alzheimer's 
research, and we funded last year some 300 such new scientists 
to be brought into the field with imaginative ideas that you 
have heard about today and some of those I have tried to 
illustrate.
    This has been one of the most exciting and productive 
aspects of scientific opportunity converging with the resources 
that you have been able to provide.
    The Chairman. I like that multidisciplinary approach. I 
think that is really important too.
    I was fascinated, what you just described about cells 
because it reminded me of a discussion that I had with a 
scientist at Harvard.
    I have visited NIH, Jackson Labs, Mayo Clinic, University 
of Pennsylvania, and a lot of different places where research 
is going on, and this researcher told me about what he called a 
``REST.'' Is that what you are talking about here? I cannot 
remember whether it is a REST protein. I think it was a protein 
that could wake up the cell and cause it to regenerate.
    It sounds very similar to what you just described.
    Dr. Hodes. It is a unique and additional example of a 
protein that normally changes with aging and its expression in 
the brain and where that normal progression and regulation is 
altered with Alzheimer's disease.
    The Chairman. That is fascinating.
    I actually could spend all day at those labs. I want to 
tell everyone here. You would be so encouraged when you see the 
dedication of these researchers and other health care providers 
who are exploring all different approaches. I know it is easy 
to get discouraged about the failed clinical trials, but, boy, 
when you talk to people in the labs, your optimism goes way up. 
It is just so exciting what is going on.
    Dr. Hodes. If I may take the liberty----
    The Chairman. Please.
    Dr. Hodes [continuing]. of inviting you, Mr. Casey, and 
members, we have had most exciting opportunities at NIH on 
campus to have delegations, individual or multiple, come to 
visit. We would love to let you see more about what goes on in 
the way of researching, including in Alzheimer's disease, so 
please take that as an open invitation at any point. We would 
love to explore with you on campus.
    The Chairman. Thank you. I will come back any day. Thank 
you.
    Mr. Jacobs, let me end my questioning by asking you a 
little bit more about care planning. Care planning is now 
recognized as such a critical aspect of dealing with the 
Alzheimer's, particularly since this disease spans so many 
years, and yet there is no one roadmap. There is no one answer 
to care planning. Each plan needs to be flexible, tailored to 
the individual. What may work well for the Hartts might not 
work for my family.
    Could you tell us more about the process of developing a 
care plan that is tailored to the individual needs of a family?
    Mr. Jacobs. Yes. Thank you, Senator.
    As we look at care consultation services, as an example, 
through the Alzheimer's Association, we know that people reach 
out to us at different aspects of the disease, to your point, 
at different points on either pre-diagnosis or after being 
diagnosed, really with changes that come along, knowing that 
disease spans years.
    The hope is to be able to provide brief counseling, be able 
to identify immediate needs there, and then be able to help 
them move on with immediate concerns.
    Often what we see throughout Pennsylvania is folks reach us 
after when we would love to see care planning already having 
occurred. We are dealing with acute situations and trying to 
help them through the next steps, and so that is why we are 
encouraging, incredibly excited as we look at the additional 
legislation being proposed, because if we can reach people 
earlier, talk about legal and financial issues, talk about 
medical management, develop a care team or a care team of 
choice, all of those things may change how people connect with 
us, may change how they experience this disease, and provide a 
little bit more hope and provide the opportunity for folks to 
live well with the disease, as we have heard from others today, 
early on and really be active and engaged in what that looks 
like in the coming years.
    The Chairman. Thank you.
    I know I said that would be my last question, but I hope 
the Ranking Member will forgive me if I ask one more, and that 
is of Mary Hartt.
    Just following up on that, you talked about how the support 
group of the younger-onset Alzheimer's helped you, but what 
about medical and other health care providers or other sources? 
Did you find help in putting together a plan, or did you just 
develop it on your own?
    Mrs. Hartt. We went to Mass General because at Dysart's, we 
had a wellness group that was able to get us the appointment, 
and when we were at Mass General, they had care plan. We met 
with a social worker. We have met with--Mike has met with a 
speech therapist. We have had, as I said in my speech, the 
doctor suggested that I get power of attorney, so it has not 
just been medical that we have been given at Mass General. It 
has been life needs, and the doctor very much has encouraged 
the living life today.
    I do not know that I would have had the strength to be able 
to be as creative as I have had I not had his advice to be 
doing this.
    The Chairman. Thank you. That is very helpful.
    Senator Casey. Thank you, Madam Chair.
    I wanted to go back to the funding question for Dr. Hodes. 
I know that you and your colleagues at the National Institute 
on Aging are making incredible progress and scientific 
discoveries every day. We know that those discoveries are not 
only focused on helping find a cure, but also on improving 
care.
    The legislation we are working on together, Chairman 
Collins and I and others, will help to continue that progress.
    I wanted to ask you. I guess my question--and I know it is 
a bit redundant, but I do not think we can emphasize it enough, 
the importance of the funding. I know maybe for even folks here 
in Washington that are used to these discussions, but 
especially for folks who do not live and work in the halls of 
Congress or do not work on these issues every day, they may 
think it is yet another appropriations request just like 
everything else, just adding funding for the purposes we 
outlined.
    I do think, though, that it is important that we emphasize 
the impact of the dollars and that this is not just another 
funding request, that it is really an investment, an investment 
in a cure, an investment in better care.
    I just want to have you walk through again. When we look at 
the chart that you showed us, $631 million in Fiscal Year 2015 
all the way up now to potentially $1.9 billion----
    Dr. Hodes. Plus this year, an addition of $425 million.
    Senator Casey. Right.
    Dr. Hodes. Approximately $2.3 billion.
    Senator Casey. Tell us what that means because I think we 
sometimes talk about the numbers, and the numbers are 
important, but what does that mean to the measure of progress 
we got to make?
    Dr. Hodes. Again, if I could just briefly outline what I 
alluded to, the way in which we generate or bypass budgets is 
tied very much to our planning, so that as a result of summits 
held each year, either in Alzheimer's disease, Alzheimer's-
related dementia, or care and services, we generate from 
hundreds of national and international leaders and advocates 
and community members, a list of the priorities for research 
and gaps.
    We translate those into milestones, to achieve any of those 
priorities, what do we need to accomplish year by year, and 
then we estimate the cost of carrying out that research.
    In addition, each year we go back to account for what was 
accomplished. In the beginning, the first metrics are we funded 
new grants, new investigators, and this is important and 
exciting by itself. I think some figures we mentioned 
repeatedly, of all the awards given, about a quarter were to 
new and early stage investigators who had no previous NIH 
support at all. These are the exciting newest generation of 
research that has come into the field. Part of what we have 
accomplished with this funding is to give them an opportunity 
to commit their ingenuity, creativity.
    Approximately a third of all of the awards we have given 
were to investigators who had never been in the field before. 
Some of them are new, but some are established investigators 
moving into the field, so these themselves are metrics.
    Now, year by year, we will ask about what the success has 
been after funding our new grants, how many new targets have 
there been identified as potential translational vehicles 
toward clinical trials. The next step will be to track the 
number of clinical trials we have instituted, and so each of 
these, year by year, we factor to monitor whether we are doing 
the appropriate and optimal job of utilizing the resources that 
come and estimating for the subsequent years what we think 
additional resources might be.
    Senator Casey. Well, you are doing something that 
Washington does not do very well, which is planning. We have 
not been accused of that much lately, but we are grateful for 
that insight.
    I do not have any more questions. I do want to mention that 
I guess while I was upstairs at another hearing, Clay Jacobs 
got the question about rural, access to folks in rural areas, 
and we are grateful to others on the panel who are addressing 
that question.
    Madam Chair, thank you very much, and again, thanks for 
this hearing.
    The Chairman. Thank you, Senator Casey.
    I want to thank all of our witnesses for being here today 
and particularly my constituents, the Hartts, who came from 
Hamden, Maine, to be with us, but each and every one of you has 
added so much to our understanding.
    I also want to thank our staff, which worked very hard, to 
put this hearing together.
    Most of all, I want to thank all of the advocates who have 
come to participate, including those of you who are living with 
Alzheimer's, those of you who are family members, caregivers, 
and those of you who are researchers, organizers, and 
advocates.
    In the puzzle to end Alzheimer's, each of you is a critical 
piece, and with your efforts, we are making progress.
    This is very personal as well as a professional cause to 
me. As I told the advocates from Maine, I lost my father a year 
ago to Alzheimer's after my mother had cared for him as his 
principal caregiver for approximately 8 years before he went 
into the Veterans Home in our hometown of Caribou for the last 
few months of his life.
    I know firsthand how difficult it is and also the stress 
placed on a caregiver, particularly one who is turning 92 next 
month, so paying attention to our caregivers as well as the 
research is equally important.
    I also lost my grandfather and two of my three uncles to 
this devastating disease, so Dr. Fekrat, I may be down to see 
you for that scan.
    I do so appreciate that sea of advocates that we see. 
Working together, I know that we can turn the tide on 
Alzheimer's, but without you, we never could have gotten to the 
funding levels that are making possible such exciting research 
that is going on today, so I am grateful for your work.
    Senator Casey, do you have any final words for us?
    Senator Casey. Just briefly, Madam Chair. Thank you, and I 
want to thank all those who are in attendance today--the 
advocates, the researchers, and of course, our witnesses who 
have given us, certainly for me and I know other members of 
this Committee, an expanded knowledge base. We learn every year 
we are here about Alzheimer's disease and related dementias and 
also the effort that has been undertaken here led by individual 
Senators, like Senator Collins, to make this not only a 
critical priority, but also a bipartisan endeavor. Those happen 
around here once in a while, and we are grateful for her 
leadership to improve both awareness and to increase resources.
    Clay, I want to thank you for representing Lackawanna 
County well. I will tell everyone back home.
    I did want to close with something that Mr. Hartt said in 
your comments earlier. You said--and I think I am quoting you 
accurately here--``I have always found my own way'' and how 
that challenge that you have been presented with challenges the 
way you have lived your life, but I think your presence here 
and the testimony and brave witness of others will help all of 
us find a way to a cure and better care, so we appreciate those 
who are standing up, like you and others, Mr. Hartt, for this 
effort. Thanks very much.
    The Chairman. Thank you.
    Committee members will have until Friday, April 12th, to 
submit any additional questions for the record, which we will 
send your way.
    Again, my thanks to every single person in this room. You 
truly are making a difference.
    This concludes this hearing.
    [Whereupon, at 11:26 a.m., the Committee was adjourned.]
   
     
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                                APPENDIX

     
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                      Prepared Witness Statements

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                       Statements for the Record

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  Slide presented by Dr. Fekrat, M.D., Professor of Ophthalmology and 
                     Associate Professor of Surgery
                     
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 Slides presented by Dr. Hodes, M.D.,Director of National Institute on 
                Aging and National Institutes of Health
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                             [all]