List of Comments
Comments and questions, or alerts to broken links, should be sent to napa@hhs.gov.
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.
J. Copeland | 11-2-2023
We appreciate the opportunity to comment at the “Advisory Council on Alzheimer's Research, Care, and Services Meeting.”
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
As you know dementia is a devastating and common condition, yet it is also very misunderstood. That’s why the NCHR encourages the Advisory Committee to develop an advocacy campaign to help educate the public to reduce misunderstandings. The symptoms of dementia and cognitive impairment can be inappropriately diagnosed as Alzheimer’s Disease, even though cognitive impairment can have many different causes.
Working to reduce misunderstandings about dementia and cognitive impairment could be enormously helpful to individuals and their families by reducing unnecessary fear and anxiety while also preventing unnecessary medical treatment. The health of individuals, families, private insurance, and welfare of government health programs are at stake.
Dementia and mild cognitive impairment can have many causes and does not mean a person has or will develop Alzheimer’s Disease. The NCHR encourages the Advisory Committee to educate the public about the preventable causes of cognitive impairment, including side effects from benzodiazepines, sleep medications, and allergy pills. Advocacy regarding the impact that social isolation and lack of physical activity can have on cognitive impairment is also critical to help reduce misunderstandings and encourage change that may drastically reduce or reverse cognitive symptoms.
H. Shah | 10-31-2023
I have the fortunate honor of representing the National Down Syndrome Society, as their Director of Advocacy and Policy. I would like to respectfully express my sincere disappointment for the ongoing absence of representation from the Down syndrome community on the NAPA Advisory Council. This is further reflected in the 2023 recommendations, where Down syndrome is seemingly listed tangentially given the alarming statistic that over 90% of individuals with Down Syndrome develop Alzheimer's disease. It is vital that this community be given a voice at the table to address the unique challenges they face, which in turn can add to the ongoing and needed growing body of Alzheimer’s research. In the following comments, I will outline the pressing need for such representation and offer recommendations on how to bridge this gap.
The Down syndrome community's relationship with Alzheimer's disease is an urgent concern that cannot be overlooked. Not only do individuals with Down syndrome have a significantly higher chance of developing Alzheimer’s disease than the general population, but Alzheimer’s has also become the leading cause of death for adults within this community. These disturbing statistics underscore the dire need for the Advisory Council to not only keep Down syndrome top of mind in its annual plan recommendations as mandated by the National Alzheimer's Project Act, but also to include someone from the community on the Council.
To address this issue comprehensively, I strongly reiterate past comments of my colleagues and urge the Advisory Council to establish a dedicated subcommittee. This subcommittee would focus on improving diagnostic and clinical support for adults with Down syndrome and intellectual and developmental disabilities, aiming to provide targeted solutions that are intentionally inclusive for individuals who cannot access these programs without modifications. Until the Advisory committee has representation from the Down syndrome community, the subcommittee would establish a process to integrate thinking and consideration of the impact of Alzheimer’s disease on the Down syndrome community for the Advisory Council.
The subcommittee's mission should encompass several key areas we highlighted in our letter to the Advisory Committee back in 2021:
Access to Adequate Clinical Care: We must prioritize the education of clinicians, both students and practitioners, to ensure they have the necessary knowledge to provide quality care to individuals with Down Syndrome and other intellectual and developmental disabilities. This includes crafting training curricula and developing resources for technical assistance.
Increased Support for Research: Research specifically aimed at understanding the intersection between Down Syndrome and Alzheimer's disease is essential. A dedicated focus on this area will help in advancing knowledge and developing effective treatments.
Access to New Alzheimer's Treatments: Collaboration with the Centers for Medicare & Medicaid Services (CMS) is crucial to ensure that new Alzheimer's therapies are affordable and accessible to individuals with Down Syndrome.
Inclusion in Clinical Trials: Promoting the inclusion of individuals with Down Syndrome in clinical trials is vital for research that seeks to develop Alzheimer's treatments and therapies. This can be achieved through regulatory or subregulatory guidance.
Access to Long-Term Services and Supports: It is imperative that healthcare providers in congregate care settings are trained in memory care for individuals with Down Syndrome. Conversely, providers in dedicated LTSS care settings must also be equipped to care for individuals with Down Syndrome and other intellectual and developmental disabilities.
Dr. Rafii highlighted the significant risk individuals with Down syndrome face regarding Alzheimer's disease and the biological reasons for it. Because of these factors, inclusion in clinical trials and equitable access to treatments are equally essential.
We believe that addressing these concerns necessitates the creation of a special subcommittee within the NAPA Advisory Council, focusing on intellectual and developmental disabilities, including Down Syndrome. Such a subcommittee would not only serve as a beacon of hope for the Down Syndrome community, providing them with the advocacy and support they deserve, but also play a critical role in research progress on Alzheimer’s.
In conclusion, I urge the NAPA Advisory Council to act swiftly and decisively to address the urgent needs of the Down syndrome community regarding Alzheimer's disease. The time for research, equity, and improved access to care is now. Let us work together to ensure that no individual is left behind, that everyone has a fair chance at a healthy and fulfilling life, and that Alzheimer's disease in the Down syndrome community is a challenge we are determined to conquer together. As a starting point, I would encourage you to consider the work of the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project. Their directive called for a new trans-NIH research initiative on critical health and quality-of-life needs for individuals with Down syndrome, and ask the project leads to provide assistance in coordinating the subcommittee.
Thank you for your time and consideration.
S. Eissler | 10-30-2023
I am the volunteer ambassador for the Association of Frontotemporal Degeneration (AFTD). I was the caregiver for my husband who had FTD beginning at age 50 and died at age 60. My oldest son also died from FTD at age 53.
After hearing the presentations today about interventions in brain disease, I would like to make 2 points. The first is that there is a population of families who have genetic variants of FTD. These families would be a ready and eager group to test interventions, since that is their only hope until there is a cure for this disease. AFTD and the FTD Disorder Registry can provide information about trials to these families. Also, it appears that there is a movement among families to begin to bring together people with the same genetic mutations and to connect them with researchers.
The second point is that there is still a huge problem with lack of awareness in the general public about FTD. (An example is the name of this group “Advisory Council on Alzheimer's Research, Care and Services" which still does not include “other dementias”.) When someone has memory issues, the first thought is Alzheimer's. But if a person ages 40-60 years becomes depressed, abuses alcohol, becomes rigid or apathetic or loses social graces, the person is usually considered the problem. When my husband first had symptoms, I had no idea he had a brain disease. He was age 50, healthy, energetic, and articulate. But within a year he had lost his job and all of his many community positions. For 6 years I went to various professionals -- priest, counselor, psychologist, psychiatrist, neurologist and they all thought he was just depressed or having a mid-life crisis. Then 6 years later, I discovered that he could not find his way home from the grocery store. I found a memory clinic, but they would not see him as he was too young. Finally, a special memory consultant for early onset problems diagnosed him. This was 15 years ago, but today the average time to get a diagnosis is still 3.6 years. Public awareness and professional awareness could change this. When good interventions and /or treatments are found, it would be a travesty to lose those 3.6 years.
Other issues:
- Now there is so much information about resources and interventions, treatments and caregiving, that it can be confusing and overwhelming. Hopefully, as we move forward, we can figure out how to consolidate information and services to be as accessible as possible.
- Financial assistance is a major issue for people with FTD. Initially it is day care and in-home care that is needed. Then for many it is care in a facility. FTD affects younger people, at a time when they would usually be at the peak of their earning power, with children still at home. One wage earner is lost and there is no extra money for care.
Thank you for the opportunity to comment.
M. Rafii | 10-30-2023
Good afternoon. I am Professor of Neurology at the Keck School of Medicine at the University of Southern California. Thank you for allowing me to speak today.
As you may know, people with Down syndrome are living longer, healthier, and more independent lives, with the fastest growing segment of this population being those over age 50. With this increase in life expectancy, however, we are seeing more people with DS being diagnosed with Alzheimer’s disease, which is now the leading cause of death in adults over the age of 35.
Over the past decade, we have discovered a great deal about the biology as to why people with DS are at such high risk for Alzheimer’s disease. The gene for the Amyloid Precursor Protein, or APP resides on chromosome 21, which, in people with DS, leads to an overproduction of APP, leading to amyloid plaques and Alzheimer’s disease. There are individuals with DS who have a partial trisomy, that is, although they have an extra copy of chromosome, they do not have an extra copy of the APP gene. These individuals do not develop amyloid plaques and they do not develop Alzheimer’s disease.
At the same time, remarkable progress is being made in the Alzheimer’s field. Results from randomized, placebo-controlled trials in the general population have shown that by removing amyloid plaques, we can slow the progression of Alzheimer’s disease.
But, despite their high risk, people with DS have been excluded from these clinical trials, which leaves the safety of these new treatments largely unknown in this group. In just the past five years, we have made significant strides in understanding Alzheimer’s disease biomarkers in people with DS. Many of these discoveries are due, in no small part, to the trans-NIH INCLUDE initiative which encourages the inclusion of people with DS into ongoing research efforts. The INCLUDE initiative has helped launch several groundbreaking studies. The Trial Ready Cohort -- Down syndrome, or TRC-DS, has enrolled nearly 200 participants who will enter clinical trials designed specifically for them. This project is being conducted by the Alzheimer’s Clinical Trials Consortium -- Down syndrome or ACTC-DS, which has leveraged the NIA’s clinical trial infrastructure to establish an international network of expert sites that serve as a platform for testing the most promising treatments safely and effectively. There is much work to be done, but through collaboration with advocacy groups, inclusion in the NAPA roadmap, and with sustained funding and support, we will succeed.