Clinical research doesn’t reflect the Alzheimer’s population. That needs to change

New data from the National Institute on Aging (NIA), part of the National Institutes of Health, show that our nation needs a fundamental shift in how Alzheimer’s research and clinical trials are designed and funded to overcome urgent health equity challenges.

Alzheimer’s — a progressive brain disease that slowly erodes memory and executive function over time — disproportionately affects people of color, yet health disparities in Alzheimer’s treatment and research remain under-addressed.

Black Americans are approximately two times more likely, and Hispanic Americans are 1.5 times more likely to develop Alzheimer’s than non-Hispanic white people, and those numbers are likely to increase. Yet these groups make up less than 10% of participants in currently enrolled NIA-funded Alzheimer’s research.

While researchers and industry often point to mistrust and participant interest as key recruitment challenges, there are systemic barriers that make it harder for people of color and people with lower socioeconomic status to participate in research that is designed to lead to better therapies and interventions for the nation’s sixth leading cause of death.

The new NIA data highlight that the eligibility criteria set by researchers — known as inclusion and exclusion criteria — have the potential to work against people from diverse backgrounds taking part in clinical trials.

An analysis presented by NIA Clinical Research Coordinator Alexandra Mitchell and colleagues at the Alzheimer’s Association International Conference on Thursday showed that 60% of NIA-funded Alzheimer’s trials have at least one exclusion criteria that could disproportionately affect Black and Hispanic participants compared to non-Hispanic white participants. These include:

• 20% of trials focused on Alzheimer’s disease and related dementias exclude participants living with depression, even though people of color are more likely to live with prolonged and chronic depression than non-Hispanic white Americans.
• 70% of trials have at least one “broad” exclusion category that is too general to be objectively defined by the researchers conducting the studies, introducing a gray area into a process that should be transparent and scientifically justified.
• 55% of federally funded trials are “English only” — effectively shutting out the 7% of Americans who don’t speak English and the roughly 8% of Americans who speak English less than “very well,” according to the U.S. Census.
• 11% of the NIA-funded trials exclude individuals with diabetes and the same percentage exclude individuals with transportation challenges — both known barriers in low-income communities.

The NIA data demonstrate that the clinical trial system is oriented toward a specific demographic that is not reflective of the Alzheimer’s patient population.

As Jennifer Manly, Andrea Gilmore-Bykovskyi, and Kacie Deters put it in a commentary for JAMA Network Open about a major Alzheimer’s trial known as the A4 Study, “participants who were White, well-educated, and well-resourced were centered at each step of the design and execution process.”

This orientation is also seen in the distribution of the nation’s 31 NIA-funded Alzheimer’s Disease Research Centers. According to an analysis led by University of Wisconsin researchers, access to these marquee research sites “skews toward the most wealthy neighborhoods.”

As people working in the Alzheimer’s sphere, we know that communities highly affected by this disease are anything but “well-resourced.” An analysis by UsAgainstAlzheimer’s and the Urban Institute found that counties with the highest prevalence of Alzheimer’s among Black and Hispanic Americans in the Medicare program tend to have worse socioeconomic conditions compared to counties with the lowest prevalence of Alzheimer’s.

Families living in these counties were less likely to have health insurance, less likely to have access to exercise opportunities, and less likely to have a bachelor’s degree or higher. At the same time, they were more likely to have lower incomes and more likely to report poor health than families living in counties with lower levels of Alzheimer’s disease.

While inclusion in research won’t solve the root causes of brain health inequities, adequate representation will help ensure that taxpayer dollars are spent more equitably and responsibly in the race to solve this pressing health challenge. We believe there are three steps the field — and specifically the NIA — can take to turn this data into action.

Improve accountability in trial design. Following in the steps of the National Cancer Institute, the NIA should work with patient advocacy groups and the Food and Drug Administration to ensure that the eligibility criteria researchers set are scientifically justified and continually evaluated for their impact on the exclusion of underrepresented populations in research.

Expand site access in underserved communities. The NIA should extend its reach beyond traditional academic medical centers by standing up research sites in communities that have a high burden of Alzheimer’s disease. For example, practice-based research networks can help extend research into underserved communities with high rates of Alzheimer’s by training and health care providers and community health centers to be part of research teams and giving them incentives to do so. Eight other NIH institutes, including the National Cancer Institute, are currently using such networks to support research efforts.

Address language access gaps. The Covid-19 pandemic has taught us that telemedicine can be a powerful tool to help ensure continuity of care and to address disparities in access to care. The NIA should apply these lessons and invest in a centralized telehealth program that connects language-proficient experts to research sites through safe and secure videoconferencing solutions. This Zoom-powered approach can go a long way in addressing the glaring access gaps impacting millions of potential participants.

Without research that represents the diversity of Americans, the Alzheimer’s research community will continue to deliver innovations that work better for some groups than for others, and lines will continue to be drawn by race and income instead of need and equity. All of us must do better.

Jason Resendez is the executive director of UsAgainstAlzheimer’s Center for Brain Health Equity. Stephanie Monroe is the executive director of the AfricanAmericansAgainstAlzheimer’s, a network of UsAgainstAlzheimer’s.