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National Alzheimer's Project Act: Public Comments on Advisory Council Meeting, July 2018

Public Comments on Advisory Council Meeting, July 2018

List of Comments


Comments and questions, or alerts to broken links, should be sent to

PLEASE NOTE: The Public Comments included here are not an endorsement of the views or information by National Alzheimer's Project Act, its Advisory Council members, the Administration or the federal agencies involved in this project.


FACEBOOK COMMENTS  |  07-30-2018

The morning sessions of the July 30 meeting were streamed live as a HHS Facebook Event. Below are the substantive comments left there during the stream.

K. Cowell Price

Is there webcast info to attend remotely?


Information on future meetings is available at

M. Blanco

Where in the Humphrey building will this be? I am from ONC and i would like to go to this event personally if I can


Meeting information and material is available online at The meeting announcement is usually available 4-6 weeks before the meeting when it is announced in the Federal Register, and other materials are added as the web team receives it. Meeting materials. A NAPA Listserv email is usually sent alerting subscribers as new material is available.

G. Thomas

HHS doesn't respond on Facebook or Twitter so I'll post this here any way. From personal experience, the Patient Protection Act does not contain enough to protect the patient. One item is hospitals should be required to keep patients Electronic Health Records in atimeline, this would help reduce unnecessary test-treatments and health providers from padding their services which increase health care cost

K. Guerra

National Adult Day Service Programs.

J. Lawton

Watching from Washington DC .Caregivers need support.

L. Hatten

Good job on all the work you all do.

C. Cuffe

The elderly need our help on this

D.K. Hill

Just discover a cure or at least treatment.

R. Mitchell

There is evidence for lifestyle change as I understand it

R. Mitchell

Lifestyle change reducing risk and reducing Dementia

T. Lyons

Thank you for supporting Alzheimer's research and care

L. Gunter Mantz

Please make these documents available. I am in the Executive Board of the RI Dementia State Plan revision. We need this information.


Meeting information and material is available online at The meeting announcement is usually available 4-6 weeks before the meeting when it is announced in the Federal Register, and other materials are added as the web team receives it. Meeting materials. A NAPA Listserv email is usually sent alerting subscribers as new material is available.

L. Gunter Mantz

Please help remove the stigma so people will seek help, and healthcare providers recognize that there are ways to treat the person so we can treat the disease.

J. Lawton

I Am a caregiver,. It took financial, physical, and emotional toll on the patient, as well as myself.we both suffered, because I didn't know the signs, and I didn't know how to get help.


A. Helsing  |  07-23-2018

As the leading human rights organization for all individuals with Down syndrome, the National Down Syndrome Society believes the importance of caregivers should not be underestimated. Last November, in honor of National Caregivers Month, NDSS and our partners released our "Alzheimer's Disease & Down Syndrome: a Practical Guidebook for Caregivers" specifically for those caring for an individual with Down syndrome diagnosed with Alzheimer's disease. We want to show caregivers that NDSS is with them every step of the way and provide resources about Alzheimer's disease gathered into one collective guide.

The prevalence of Alzheimer's disease in the Down syndrome community is very high. This guidebook was written to help empower the caregivers and families with knowledge and guidance about the connection between Down syndrome and Alzheimer's disease, how to carefully and thoughtfully evaluate changes that may be observed with aging and how to adapt and thrive within an ever-changing caregiving role when a diagnosis is made.

Individuals with Down syndrome are now going to college, getting competitive jobs, getting married and living long, full lives. We know this guide will be an amazing resource for the caregivers of those with Down syndrome as they age.

We encourage everyone on the Advisory Council to click HERE or visit our website at under Publications to obtain this vital resource.

If you have any questions, please contact the NDSS Director of Government Relations.

We look forward to working with the Advisory Council on these important issues.


J. Dwyer  |  07-23-2018

The Capacity of Alzheimer's Disease Clinical Trial Sites Unlikely to Meet the Demands of Pending Therapeutic Clinical Trials


While attention is often given to the Alzheimer's disease (AD) pipeline and successful recruitment, the capacity of current AD trial centers to enroll and execute these trials is equally important. Even if we can recruit qualified participants, sites that can accommodate these participants are limited. The Global Alzheimer's Platform (GAP) Foundation estimates that the number of qualified sites in North America to conduct pending AD clinical trials represents less than 50% of the number of sites required to meet the demand of AD clinical trials in the pipeline. This shortage puts the timely discovery of a cure for AD at risk.

Focusing on the capacity challenge in AD trials will reduce the time and cost of AD clinical trials, and-- more importantly -- will increase the likelihood that all the trials currently anticipated are completed on a timely basis thereby speeding the delivery of innovative medicines to those suffering from or at risk of AD.

GAP Site Network

List of Alzheimer's Disease Clinical Trial Network Research Centers.


Researchers Against Alzheimer's (RA2) publishes an annual AD development pipeline. According to the 2017 RA2 report, 55 phase 2 or 3 complex therapeutic trials for treatment or prevention of AD/Mild Cognitive Impairment (MCI) will be enrolling in 2018-2019*.1 Approximately 25,277 participants will need to be randomized for these clinical trials in North America in the next 24 months.

Global Alzheimer's Platform Network (GAP-Net) metrics were used to calculate the current capacity of the field to meet this level of enrollment. GAP-Net consists of 62 AD trial centers, both private and institutional, dispersed across North America. GAP collects metrics from its sites on recruitment and site performance. Data gleaned from GAP-Net were used to extrapolate the predicted performance of the whole field.

In 2017, GAP-Net sites randomized an average of 25 participants per site into comparable phase 2 and 3 therapeutic trials. Extrapolating this average to all sites over 2 years, GAP estimates that a total of 505 sites (including GAP-Net sites) would be needed to randomize 25,277 participants in AD clinical trials.

25,277 Participants, 505 Sites, 55 Completed AD Clinical Trials.

There is no absolute agreement on how many sites in North America are equipped to conduct the trials described in the RA2 report. GAP, and other observers of the field, conservatively estimatethat there are approximately 200 qualified AD trial sites in North America. Therefore, site demand exceeds capacity by 250%. These projections pose important questions about how the field will address the need to complete clinical trials in a timely fashion.


Total # Sites Needed as Capacity Increases.

If current GAP-Net site capacity could be increased by 50% (+12.5 participants per year) through GAP's optimization efforts and capital investment, 30 fewer sites would be needed. Based on GAP-Net's projected growth in 2018 to a total of 100 GAP-Net sites, if the number of participants could be increased by 50%, 50 fewer sites would be needed. Even a modest increase of 10% improvement in enrollment across 100 sites would result in 10 fewer sites being needed overall.


GAP is analyzing a number of tactics in the face of this strategic threat. GAP's strategy for addressing the problem of limited site capacity is to enable sites to perform more efficiently and thus better employ their current resources as well as to invest more resources into sites.

AD Research Site Current Capacity = GAP Direct $ Investment + GAP SSU Improvements + GAP Improving Site Efficients = Optimized AD Research Site Capacity.
  • By building an organized consortium of sites -- all focused on operational improvement and enrollment innovation -- GAP is increasing site capacity or, in some cases, creating new capacity to enroll participants. Similar models exist in other therapeutic areas such as cancer and stroke.

  • In addition, GAP is investing and stimulating investment to improve infrastructures. In previous research, GAP has been able to show that investing in site infrastructure can substantially increase enrollment.2

  • GAP facilitates and supports GAP-Net site start-up (SSU) activities including a central IRB, common contract template, and a high-touch concierge start-up model.

  • GAP has developed its Site Process Optimization program to improve the efficiency and effectiveness of the study pre-screening and screening processes through formal process evaluations.


To successfully execute trials in the AD pipeline, changes to the current system are critical. GAP's projections suggest that many pending trials cannot be completed on schedule without addressing the shortage of clinical trial capacity. It's likely that these changes will come from a broad spectrum of solutions. GAP-Net is poised to increase site capacity both by increasing the total number of sites, shortening the duration of AD clinical trials, collaborating in infrastructure investment, and facilitating site optimization activities.

In addition, GAP is incubating novel pre-screening technologies which are intended to reduce the rate of screen failures, thereby creating additional site capacity. While GAP believes these tactics will make a significant contribution to reducing the shortage, larger and more systemic strategic programs need to be considered to close the gap between pending AD clinical trial demand and the supply of clinical trial sites in North America.


1 Alzheimer's Drugs in Development Pipeline. UsAgainstAlzheimers Web site. Released July 2017. Accessed June 7, 2018.

2 RichardMohs, Gabe Goldfeder, et al. Novel Recruitment Strategies for Clinical Trials. Oral presentation at 2017 Alzheimer's Association International Conference; July 2017; London, England.

* The RA2 report that was recently released in July 2018 did not materially impact our results.

Contact Information

GAP Foundation: Website:


R. Mohs, G. Goldfeder, J. Bork, J. Dwyer, & D. Beuregard, The Capacity of Alzheimer's Disease Clinical Trials Sites Unlikely to Meet the Demends of Pending Therepeutic Clinical Trials, 2018. [Available as a separate link:]


M. Janicki  |  07-23-2018

Dr. Keller and I are the co-chairs of the National Task Group on Intellectual Disabilities and Dementia Practices (NTG) ( The NTG is an affiliate of the American Academy of Developmental Medicine and Dentistry and is associated with the Rehabilitation Research and Training Center on Developmental Disabilities and Health at the University of Illinois at Chicago.

Dr. Keller and I want to use the public comments opportunity to raise before the Council an issue that continues to have resonance -- the need to enhance supports to families and others who are the primary caregivers for adults with intellectual disability affected by dementia resulting from Alzheimer's disease and other related causes. Recently, the Wall Street Journal noted on its front page the issue of the declining reservoir of caregivers for our aging population and the need to shore up supports for caregivers nationally. The article noted that "today, an estimated 34.2 million people provide unpaid care to those 50 and older *** and help keep people out of costly institutions" and went on to cite the at-times dire situations of affected persons lacking home-based supports.i The article focused on the both the lack of persons, both paid and un-paid, who could aid with caregiving, and the growing unfulfilled needs of existing caregivers wrestling with providing care for the many persons affected by Alzheimer's disease.ii

The NTG recognizes that home-based and familial caregiving, as well as the resources to enable it, is an issue facing many families in the general dementia care community and wants to emphasize that these same concerns resonate broadly throughout the community of long-term family (and other) caregivers of persons with intellectual disability. Given this context, this is an issue that we wish to again bring up before the Council.

In a recent article published in the journal, Alzheimer's & Dementia: Translational Research & Clinical Interventions,iii the authors presented the updated findings and recommendations that stemmed from a pre-summit report originally submitted to the 2017 National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers.iv The information in this article should have much interest to the Council as it discusses and formulates its next update to the National Plan to Address Alzheimer's Disease.v

The article noted that as the population of older adults in the United States continues to rapidly increase, this group will likely need additional services and supports. Caregivers of adults with intellectual disability and dementia face many of the same challenges as do caregivers of other older adults with dementia. However, they often experience unique patterns of caregiving, face additional challenges and stressors, and draw from different sources of support and education.

The article related that the working group that produced the report examined five major areas related to programs and caregiving: (1) challenges of dementia; (2) family caregiving interventions; (3) supportive care settings; (4) effects of diversity; and (5) bridging service networks of aging and disability. Relevant key points made in the article included:

  • Early diagnosis is essential to ensure timely interventions, such as medication for symptom management, establishing advance care plans, and psychosocial interventions for both the adult and his or her caregiver.

  • There is a need for increased diagnostic competency among diagnosticians, more public awareness in general, and accessible information designed to raise the "index of suspicion" for caregivers of persons with intellectual disability.

  • Dementia-related caregiving in this group poses idiosyncratic challenges and manifests special demands, as caregivers need to be more alert to subtle changes in function due to the presence of lifelong impairment and confront the need to transition from routine care--on the presence of an intellectual disability--to specialty care and adapt to stage-related changes when dementia becomes evident.

  • There are differences among adults with intellectual disability and dementia in their trajectory of dementia (often with earlier onset of dementia), a shorter duration of dementia, and diagnostic difficulties given lifelong neurocognitive limitations and the fact that some adults will require lifelong services and supports, including family caregiving or supported living outside the family home.

  • In many instances, other kin--primarily siblings--play a significant supportive caregiving role for adults with intellectual disability when their parents are no longer able to provide care.

  • Lifelong caregivers often have different experiences from later-life caregivers with respect to adaptation, ascendance to caregiver roles, and with mobilizing and drawing on distinct networks of support.

  • Like other caregivers, those of adults with intellectual disability and dementia cope with changing behavior and associated declines, seek out information and resources to help with sustaining caregiving, try to obtain help with diagnostics and advice on interventions, contend with financial and residential care planning, and seek counsel on dealing with advanced dementia and end-of-life care.

  • Adults with intellectual disability who reside in specialty dementia care group homes often transition from regular group homes or from family homes and may remain in such dementia care homes for up to 10 years; given this, a greater investment in research on community dementia-capable care and the identification of best practice applications geared to stage-related functional decline is warranted.

  • Research dedicated to understanding the course of dementia and the impact of caregiving has in large part excluded (or not actively included) people with intellectual disability in study populations.

  • There is a dearth of research exploring varying cultural perceptions of dementia among caregivers of adults with intellectual disability and what norms exist for extended caregiving, which often leads to a misalignment between public policies and state services, and meeting family caregiving needs among some culturally distinct groups.

  • Public policy targeting caregivers of adults with intellectual disability isn't usually sufficiently sensitive to the needs of variations of "minorities" and diverse geographic conditions (such as living in rural or remote settings), and consequently may not always adequately reflect cultural and geographic awareness.

  • Professionals in the field of aging often do not feel adequately prepared to work with and/or meet the needs of persons aging with lifelong disabilities or individuals with early and mid-adulthood onset disabilities; thus, more work is needed in bridging aging and disability services to help find solutions to deficits in awareness and ideological differences that may hinder cross-network collaborations.

The working group report recommended overall that there be increased supports for caregivers of adults with intellectual disability and dementia; increased research on community living settings related to people with intellectual disability (and including caregivers of persons with intellectual disability in dementia research); acknowledgment of the influence of cultural values and practice diversity in caregiving; increased screening for dementia and raised public and professional awareness; and leveraged integration of the nation's aging and disability networks.

Pointedly, the article also noted that there are many similarities between the needs of caregivers who are caring for adults with intellectual disability affected by dementia and those who are caring for other adults similarly affected. Both need targeted aid with early detection, help with accessing diagnostic services, counseling, and aid with planning for the future, as well as assistance with housing modifications, information about care management, and other special services that help with caregiving as dementia progresses. However, a barrier to meeting these needs is that often this group of caregivers is not considered in general planning and provision of needed dementia caregiver support services.

One last point, as it was noted this past week at the Alzheimer's Association International Conference 2018 in Chicago, neurodegeneration in adults with Down syndrome (an intellectual disability with high risk for Alzheimer's disease) can be biologically detected from about the early 30svi, which means the genesis of the disease begins early in this group and may lead to early onset usually noted in the early 50s. If undetected or untreated, the disease can have profound effects on adults with Down syndrome, typically leading to death within one to seven years following diagnosis. Given this, any initiatives designed to compensate for potential early neurodegeneration, increase brain health, and modify dysfunctional lifestyles early in adulthood can be beneficial. To this end, the NTG is pleased to report to the Council that it has entered into discussions with the AARP and the National Down Syndrome Society, to create an adaptation of the AARP's and the Global Council on Brain Health's existing campaign on brain health for use with the intellectual disability community. It is our goal that although research is still on-going as to the genesis of Alzheimer's disease, collectively we can aid families utilize now whatever information is available to delay the onset of cognitive decline and behavioral dysfunction in adults with Down syndrome (and other intellectual disability). It is our hope that the Council will support these efforts and incorporate designs and aims for these initiatives into the upcoming update of the National Plan.

In bringing these articles, reports, and initiatives to the attention of the Advisory Council on Alzheimer's Research, Care, and Services, we trust that this information and the recommendations related to caregiving and intellectual disability will be integrated into the next iteration of the National Plan Update -- especially as this group of adults and their caregivers are one of the 'populations disproportionally affected' as noted in the original National Plan.viiTo this end, the National Task Group stands ready to assist and contribute to such efforts.

  1. Ansberry, C. (2018). U.S. is running out of caregivers. Wall Street Journal, July 21, 2018, pp. A1, A10.


  3. Heller, T., Scott, H.M., Janicki, M.P., & Pre-summit Workgroup on Caregiving and Intellectual/Developmental Disabilities. (2018). Caregiving, intellectual disability, and dementia: Report of the Summit Workgroup on Caregiving and Intellectual and Developmental Disabilities Alzheimer's & Dementia: Translational Research & Clinical Interventions (e-print, ahead of publication).

  4. Heller T, Scott H, Janicki MP, and the Pre-Summit Workgroup on Caregiving and Intellectual/Developmental Disabilities, Caregiving and intellectual and developmental disabilities and dementia. Report of the Pre-summit Workgroup on Caregiving and Intellectual and Developmental Disabilities. Chicago: Department of Disability and Human Development, University of Illinois at Chicago; 2017. Available at:

  5. National Plan to Address Alzheimer's Disease. US Department of Health and Human Services. (2012).

  6. Carmona-Iragui, M. (July 2018). Plasma biomarkers diagnostic performance to diagnose Alzheimer's disease in Down syndrome. Paper presented at the AAIC/ISTRAART Down Syndrome PIA meeting, Chicago, Illinois (July 21, 2018).

  7. National Plan to Address Alzheimer's Disease. US Department of Health and Human Services.(2012).


P. Gann  |  07-20-2018

As the parent of a 46 year old daughter with Down syndrome I am very interested in the work of the Advisory Council for the National Alzheimer's Project Act. As you know people with Down syndrome have a very high incidence of Alzheimer's which appears earlier than the general population and progresses more rapidly. I found the presentation of the DIAD population very interesting and compelling but that population has a lower risk of developing Alzheimer's disease than those with Down syndrome. In addition there is uncertainty and a lack of good medical services to deliver a diagnosis and programs to address the issue when diagnosed. This problem is only going to grow as the baby boomers' children (in the case of Down syndrome often later in maternal life) reach their 40's and above. Now is the time for developing strategies to address this specific population when planning for the general population.

My daughter, Kyle, is enrolled in the NIA's study on Alzheimer's disease and Down syndrome searching for biomarkers. It was not an easy study for her involving a long MRI, PET scan, lumbar puncture, blood work and cognitive and memory testing but she managed to complete the needed tests and is prepared to return when called. It was disappointing not to receive the results of that testing. I hope you will be hearing reports of this study as it progresses.

While Kyle manifests the symptoms of Mild Cognitive Impairment, her condition has not progressed. Her family and I are prepared for this to change in the future and feel this gives us time to reach out to people like you. We do not want you to forget the people with Down syndrome now suffering and failing as the result of Alzheimer's disease. We do not want you to forget the aging parents caring for their failing children. We do not want you to forget the brothers and sisters left to manage their siblings while caring for aging parents. We do not want you to forget Kyle and the others like her who have worked so hard to be a part of our society and are now facing the prospect of being decimated by this terrible disease.

Please see that this population is considered and that their voices are heard as you meet.

This is Kyle...remember her.

Photo of P. Gann's daughter Kyle.


T. Morrison  |  07-19-2018

I would like to address regression and the frequent misdiagnosis, or would it be more proper to say incorrect diagnosis, of Alzheimer's disease and or dementia for very young people with Down syndrome. I know, from personal experience how difficult it is to get an accurate diagnosis when our loved ones with Down syndrome start showing decline and loss of skills.

Here is our story:

This regression is crippling people like my 27-year-old son who, at around age 21, was showing regression. His quality of life was slowly diminishing from being an active young man in his community and in school, to sitting in a chair and staring at walls. Jonathan spent days sitting in a bed when his confusion was so high.

So, these are some of the things that happened when my son started to have regression. First, depression for both him and me, as his caregiver. At one point, about two years after his regression began (and we still had zero answers about why this was happening) the regression was getting worse. His confusion caused him to be angry, and he started to hit and abuse others that were trying to help him. He stopped activities he loved such as going to school, going to jobs with the job coach, going to fun activities like dances, playing baseball, and riding his bike.

Our depression grew and mine got so severe that I was nearly hospitalized for mental health. My family was falling apart because I was focused so highly on what was wrong with my son. I was unable to properly mother and care for my teenage daughter.

By the time I found the online caregiver support group sponsored by the NTG, and the day I finally reached out to the Alzheimer Society I was suicidal. I don't like sharing this, but that's the reality. It was at that very low point that I started thinking about the quality of my son's life. It was all consuming. With the help of the leaders of the online group and my local Alzheimer's Association, I was able to start looking at causes for his aggression and some solutions.

This terrible time in our lives could have been avoided, I believe. It took over a year before we learned that my son does not have Alzheimer's (although most of the signs he showed looked like Alzheimer's disease). He has Down syndrome Regression, which means he has lost skills that he won't regain -- but he isn't dying from Alzheimer's.

My ask today is that the NAPA Council work with people like those in the NTG to help doctors understand the difference between Down syndrome Regression and Alzheimer's. I would like to make it easier to figure out what is truly wrong with the young adults who are showing regression. If there is a medical reason, perhaps it might be addressed with treatment or medication so that their lives can improve, possibly allowing them to relearn skills they had previously. There needs to be a medical checklist available to doctors, especially neurologists and psychiatrists, and others who work with people with intellectual disabilities, especially people with Down syndrome.

Thank you for the opportunity to share our experience related to a misdiagnosis of Alzheimer's disease and the turmoil that created for my son and our entire family.


S. Sozansky  |  07-19-2018

First, I would like to thank the Advisory Council for giving me the opportunity to address them today. I am here on behalf of The Association for Frontotemporal Degeneration (also known as AFTD), as well as the FTD community as a whole. I will start by saying that I have been directly impacted by FTD. My father was diagnosed with the disease in 2008 at the age of 58. His symptoms became noticeable when it was discovered that he had difficulty typing on a computer, putting words together, and when he began to exhibit unusual behavior. I would be remiss not to include the fact that my father was a well-known attorney with aspirations of becoming a judge. He was a brilliant man who had a passion for social issues.

My father's battle with FTD was long and arduous, and lasted 8 years before his death in 2016. I watched him decline little by little until he was a shell of a man with nothing left but the emptiness in his eyes. There is nothing more devastating than watching a person slowly lose their personality, their memory, and their ability to speak until all that remains is their physical presence.

And while this experience was devastating, I know my family is not alone in this journey. There are thousands of individuals, caregivers, and families battling FTD on a daily basis without any access to resources. As a lead volunteer for AFTD, I frequently receive phone calls from family members of individuals diagnosed with FTD who have nowhere to turn. The desperation and confusion in their voices haunts me as I struggle to offer them my knowledge or connect them to AFTD. I am here today to ensure that you remember FTD and my father by asking that you continue to improve upon and expand the resources that are included in the National Plan. Specifically, that you take the needs of younger caregivers and patients, the financial impact of FTD, and the need for better long-term support service options into consideration when updating the National Plan. It is imperative that other individuals and families battling FTD have unrestricted access to the necessary resources that can assist them. Thank you for your time today.