When Chris Tann was diagnosed with frontotemporal dementia, he and his wife Debra drove seven hours, each way, to Vanderbilt University in Tennessee to participate in a clinical trial, returning several times each year for follow-up visits. Clinical research in or around their community in Valdosta, Georgia, was virtually nonexistent.
Debra Tann, who is a certified dementia educator, has a front-row seat to the disproportionate impact Alzheimer’s disease and related dementias have in communities of color. She has lived in Valdosta, a city of 56,000, whose population is primarily Black, for three decades and has made it her mission to educate and empower members of her community to participate in clinical research. Beyond simply promoting equity, what’s at stake is the development of tailored treatments that could help stop dementia in communities of color nationwide.
Clinical trials have long been hindered by a lack of diversity, where people of northern European descent are significantly overrepresented and Black, Latino, Asian and Indigenous peoples are left out. This problem is especially acute for Alzheimer’s disease. For example, the phase 3 trial of the promising new drug donanemab enrolled 1736 people, but only 35 Black and 59 Hispanic participants, representing 5 percent of the study. Likewise, lecanemab, the first Alzheimer’s drug to receive full approval by the U.S. Food and Drug Administration, was tested in a 1,795-person trial, but only 2.5 percent of the participants were Black and 12.5 percent Hispanic.
Across more than 100 Alzheimer’s drug trials, 95 percent of participants were white, a percentage that’s remained stubbornly high over the past 20 years. The lack of representation may be even greater than these numbers would suggest because Black patients are twice as likely as white patients to have dementia, while Hispanic patients are 1.5 times as likely. “The vast amount of our research and understanding of Alzheimer’s—and other related dementias—are based on these rarefied, highly educated, high socioeconomic status, non-Latinx white samples,” says Monica Rivera-Mindt, a professor of psychology at Fordham University.
Despite their higher rates of dementia, people of color more often fail to qualify for trials than white people. In general, marginalized groups are ruled out because they have a higher rate of comorbidities and their blood screenings reveal lower levels of Alzheimer’s pathology than white people with similar disease progression. In addition to steering Alzheimer’s research and development away from people of color, these disparities draw into question our understanding of the disease itself. “It’s a terrible waste of time, efforts and resources to start going down the wrong path for the next 30 years because we don’t understand the differences in disease biomarkers between people of differing ancestries,” says Nancy Lynn, a senior vice president at the BrightFocus Foundation and co-leader of the project engaging local communities in Alzheimer’s research in Valdosta. “Brain health equity begins in the lab.”
Reversing decades of underrepresentation is not a short-term project, and it involves years of building trust among clinicians, researchers and everyday people. Through community-based programs, scientists and activists are beginning to do the work of bridging the gap between the medical establishment and local communities. The program in Valdosta and another in Rio Grande City, Texas, demonstrate the need to move beyond a one-size-fits-all approach and toward a more personalized model for Alzheimer’s clinical trials.
Community-led trials
Even though Starr County, Texas, has the country’s highest dementia rate—more than a fifth of Medicare beneficiaries are affected—Alzheimer’s clinical trials had never been conducted in the county. In 2021, however, the El Faro Health and Therapeutics opened its doors with the mission of enlisting the community of Rio Grande City, an overwhelmingly Hispanic enclave, in clinical trials.
The clinic was started by Antonio Falcon, a trusted healthcare professional and a pillar of his community. When his son, James Falcon, returned home after serving as an emergency room physician in the U.S. Army, they decided to tackle the challenge of bringing local residents into the mainstream of Alz-heimer’s research.
With support from the Global Alzheimer’s Platform, El Faro has focused on providing more opportunities for Latinos to participate in Alzheimer’s research. Jessica Cantú, a nurse practitioner and the site director, hosts community events twice each month, where she explains to members of the community how “research” differs from “experimentation,” how safeguards like consent forms protect participants, and why it’s important to be represented in clinical trials. “I always tell them: We got Tylenol and Ibuprofen. How did we get them? They had to be researched,” she says. “You may not know that because us Hispanics weren’t asked to participate in this research.”
Cantú has also helped launch several clinical trials, including one that tests whether donanemab can prevent Alzheimer’s. Funded by Eli Lilly, this trial is enrolling 65- to 80-year-olds who have evidence of amyloid plaque in their blood, an Alzheimer’s biomarker, but no dementia, to determine whether donanemab can slow Alzheimer’s progression when compared to placebo.
For people who don’t meet the inclusion criteria for these trials, El Faro has launched an observational study open to anyone 18 and older, where people take memory tests on their phone or computer every three months. Part of a larger global study funded by the Davos Alzheimer’s Collaborative, the El Faro study is a digital phenotyping study, which uses data from personal digital devices to study human behavior with the goal of better understanding the causes of dementia.
Educate, give, then enroll
In Tann’s community in Valdosta, a third of households make less than $20,000 a year. A lack of public transportation and healthcare providers who are people of color are additional barriers to accessing quality healthcare, as well as significant levels of mistrust in the healthcare system, stemming from a long history of discrimination and structural racism. Tann, who founded a dementia advocacy group called Reminiscent, says that many of her neighbors associate “research” not with hope and opportunity, but with past atrocities such as the Tuskegee study of untreated syphilis and a legacy of transactional arrangements. An effort to immediately try and enroll residents would likely have failed.
As a result, Tann is focusing first on educating people about dementia, partnering with them, and winning their trust. For two years, with support from BrightFocus Foundation, she has held more than 100 community events in Valdosta, ranging from dementia-specific activities like educational workshops and quarterly brain health screenings to more general community-building exercises. These include offering complimentary fitness classes for community members, producing free informational webinars specific to Valdosta, hosting community dinners and a holiday party for elders, organizing a Respite Cruise for caregivers, and providing dementia training for professionals and families.
The ultimate goal is to bring a brain health center to Valdosta that will conduct clinical trials, train providers in dementia, and engage everyday people in prevention. By partnering with the community to provide these health-promoting activities, the Valdosta program aims to establish trust and educate people about brain health, likely offering spillover benefits for other conditions like diabetes and cardiovascular disease.
“We are taking ‘the backdoor approach’,” Tann says. “We are not in the face of our community; we’re tiptoeing in to find out where they are.”
Building trust and understanding requires moving at the pace of the community, rather than following a specific mandate. For now, Tann plans to begin recruiting community members in mid-2024 for a research study that people can participate in from their homes.
This article is part of The New Age of Alzheimer’s, a special report on the advances fueling hope for ending this devastating disease.
