National Center for Health Research Written Public Comment to Advisory Council on Alzheimer’s Research, Care, and Services Regarding Plans for Updating the National Plan to Address Alzheimer’s Disease for 2026-2035.
February 11, 2026
The National Center for Health Research appreciates the opportunity to share our views on ways that the U.S. Department of Health and Human Services can improve the lives
of people with Alzheimer’s Disease and other dementias as well as their caretakers, and improve research on products that can help delay, prevent, and treat these diseases.
Our nonprofit research center does not accept funding from entities that have a financial interest in our work. We will focus on two issues regarding research and federal policy that we have worked on for many years.
Research on Alzheimer’s Anti-amyloid Drugs
At the time that the FDA approved Aduhelm, Leqembi, and Kisunla, less was known about the genetic causes of Alzheimer’s Disease than is known today, and that knowledge is continuing to increase. In addition, diagnostic testing for Alzheimer’s has improved. We strongly support Medicare’s requirement for registries for patients taking anti-amyloid drugs, because the drugs have serious risks as well as evidence of benefits, and we need to know which patients are most likely to have benefits that outweigh the risks in the real world. This is essential because not all patients with amyloid beta-plaque have cognitive impairment and some will never develop dementia. In addition, we now know that patients with APOE3 or APOE4 may comprise more than 75% of Alzheimer’s patients but also most likely to develop the brain swelling and brain bleeding known as ARIA.
Under the CMS Coverage with Evidence Development (CED), patients are eligible for Medicare coverage if they are enrolled in one of these four registries:
CMS Registry: The Anti-Aβ mAb CED Study
Clinicaltrials.gov number: NCT06058234 Study Description/Summary (PDF)
CMS Approval Date: 07/06/2023
ALZ-Net Registry (Alzheimer’s Association): Alzheimer’s National Registry for Treatment and Diagnostics
Clinicaltrials.gov number: NCT06170268
CMS Approval Date: 1/29/2024
Emory University Registry: Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry
Clinicaltrials.gov number: NCT05999084
CMS Approval Date: 11/14/2023
Beth Israel Deaconess Medical Center Registry: A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer’s Disease
Clinicaltrials.gov number: NCT05925621
CMS Approval Date: 07/11/23
The three registries that are run by private entities under CMS rules are not required to provide de-identified raw data that can be independently analyzed or detailed data that
can be vetted to any agencies in HHS or any other independent researchers. They are only required to provide a summary of results, similar to a medical journal article, which
may not include all of the kinds of info that potential patients, family members, and physicians need. It’s been more than 2 years, and none of the results have been published in a peer-reviewed journal. Although summary results from the ALZ-Net registry have been made public, they include Aduhelm patients, even though Aduhelm is no longer on the market. They do not compare the data of Leqembi and Kisunla, even though patients and physicians want that information in order to make informed decisions regarding which of these treatments might be more beneficial or more dangerous. And they provide very general information rather than the more detailed information that would help patients and physicians determine whether patients with specific genetic, physiological, or other traits are more likely to benefit or be harmed.
We therefore recommend that the Advisory Council will:
1. Require that CMS publicly release results that compare the risks and benefits of the different drugs used, as well as subgroup analyses by genetic information, amyloid information, cognitive function, and relevant demographic information.
2. CMS should require that detailed data be provided annually to CMS and made publicly available by each Registry separately for the different drugs used, as well as subgroup analyses by genetic information, amyloid information, cognitive function at baseline, and relevant demographic information.
3. Require that the private registries make de-identified data for individual patients so that CMS or NIH can independently analyze the data.
Protecting the Lives of Patients with Dementia
There is clear evidence that Alzheimer’s patients and other dementia patients are often given atypical anti-psychotic medications such as Seroquel, Rexulti, Risperdal, and
Zyprexa to calm agitation and behavior problems, even though there are numerous well-established serious risks including sudden death, and recent research indicating
that these drugs increase the risk of heart failure, pneumonia, and other very serious diseases. We understand that agitation and other behavior problems can be harmful to
the patients and their caregivers, but it is also well known that these drugs can be used to overly sedate these patients and can be deadly. CMS and other experts have
attempted to reduce the inappropriate use of these drugs, especially in nursing homes, because of their risks. Nevertheless, atypical antipsychotics, benzodiazepines, and
other similar central nervous system drugs continue to be inappropriately used by approximately 25% of older patients with dementia.
These issues become especially salient in light of HHS concerns about SSRI anti-depressants, which clearly pale in comparison to the known danger of atypical antipsychotics for vulnerable dementia patients. Most atypical antipsychotics have a boxed warning not to be used with dementia patients, but are used anyway. In contrast, FDA approved Rexulti for dementia patients with agitation in 2023, despite these concerns.
We therefore urge the Council to:
1. Recommend HHS to review available data on the recent use of atypical antipsychotics for dementia patients, focusing on whether risks outweigh the benefits;
2. Recommend that HHS conduct or fund new research on Rexulti’s use with dementia patients;
3. Urge HHS to use evidence-based research to determine how the inappropriate use of these drugs can be reduced, especially in nursing homes that receive CMS funding.