More Latinos than white Americans die of Alzheimer’s. But the clinical trials testing the drugs that could help them have mostly white participants. Alzheimer's expert Maria Aranda has a new set of trial enrollment guidelines to bridge that gap.
This article is part of the series Diversity & Dementia, produced by Being Patient with support provided by Eisai.
Some of the United States’s most widespread diseases affect different groups of people differently. Women are more likely to live with arthritis and certain types of chronic pain than men. Black Americans are 30 percent more likely to die from heart disease than non-Hispanic whites. Americans of Hispanic descent are 70 percent more likely to be diagnosed with diabetes than their white counterparts. Some of these factors are socioeconomic. Others are genetic, and scientists are still untangling the relationship between race and health risk. One of the most dire areas in U.S. public health is Alzheimer’s, which affects certain groups dramatically more than others.
And yet, according to Alzheimer’s expert and professor María Aranda, the majority of clinical trials — across all these health issues, but particularly Alzheimer’s — are still conducted using mostly white participants, and white men at that. Even when different groups carry a disproportionate burden of the disease, clinical trials that test diagnostic tools and treatments for all people aren’t accurately representative of the populations that need these medical innovations most. Aranda, with her colleagues at the University of Southern California’s Alzheimer’s Disease Research Center, is zeroing in on the lack of representation of Latinos in Alzheimer’s research.
Involving more Latinos in Alzheimer’s clinical trials is a dire need: Research shows that Americans with a Hispanic background are one-and-a-half times as likely as white Americans to develop Alzheimer’s disease. In fact, some majority-Latino counties in the U.S. were recently included on the list of the top 10 highest Alzheimer’s risk counties in the nation, where some one in six residents develops Alzheimer’s within their lifetime.
Despite this, fewer than 4 percent of participants in the drug trials for both Alzheimer’s anti-amyloid drugs aducanumab (on the market as Aduhelm) and donanemab (still underway) were Latino. In the drug trials for fully FDA-approved Alzheimer’s drug lecanemab (Leqembi), 12.4 percent of total participants were Latino — a higher number, but still quite a ways off — an over 50-percent gap — from being accurately representative of the overall U.S. population, which is 19.1 percent Latino.
These numbers seem extremely low, but according to Aranda, these trials are outliers for having any Latino participants at all.
“We’ve already spent maybe billions of dollars in the last four decades [on diversifying trials], and yet less than 5 percent of these trials include underrepresented groups like Latinos and African Americans. That’s a travesty,” Aranda told Being Patient.
“We’ve already spent maybe billions of dollars
in the last four decades [on diversifying trials],
and yet less than 5 percent of these trials include
underrepresented groups like Latinos and African
Americans. That’s a travesty.”
Collaborating with her colleagues at at the University of Southern California’s Alzheimer’s Disease Research Center, Aranda set out to fix the problem. She has spearheaded the development a set of guidelines — recently published in the journal Alzheimer’s and Dementia: Translational Research & Clinical Interventions — to improve Latino representation in trials.
Born just a mile from the USC Health Sciences campus, Aranda’s experiences as a first-generation college student, and first-generation U.S.-born Latina inspired her to start her career as a clinical social worker focused on geriatrics and gerontology. She soon found that many patients with memory loss and their families would see her in the clinic. They couldn’t speak English but heard that Aranda could speak Spanish. The families were worried about their loved ones and couldn’t access other medical services or receive a diagnosis because they didn’t speak English.
She devoted her research to seeking ways to improve Latino inclusion in scientific research — and make it easier for them to access the healthcare services that they need. Today’s she’s internationally recognized for her contributions to the field of social work.
“All of these years we’ve put the onus of not participating on Latinos and their families, Blacks and their families and on other underrepresented groups, and we’re missing the boat there,” Aranda said. But these guidelines target the many systemic issues that must be addressed to bridge this gap.
“All of these years we’ve put the onus of not
participating on […] underrepresented
groups, and we’re missing the boat there.”
A new, more inclusive framework for Alzheimer’s clinical research
Aranda and her colleagues see the new clinical trials framework as a call to action for decision makers to address the lack of diversity in Alzheimer’s research. Excluding Latinos and other ethnicities in clinical trials “goes against all rigorous scientific thinking,” she said.
In developing their new framework to fix the problem, first off, Aranda’s team found, funding agencies and pharmaceutical companies aren’t spending enough on recruitment.
“We want to make sure that they put their money where their mouth is,” Aranda said. There is no penalty for trials that underspend and fail to meet recruitment goals as a result. They are still reimbursed by grant funding agencies. “If we keep refunding individuals that missed the [diversity] target, what type of message are we giving?”
But, she worries, the decision makers across different agencies might not recognize the problem. “We need more Latino executives and scientists at those levels making decisions regarding funding,” Aranda said.
“If we keep refunding individuals that missed
the [diversity] target, what type of
message are we giving?”
Next is ensuring trials are actually accessible.
According to Aranda, this means embedding representatives and trials in Latino communities. Trials need to start disseminating information in Spanish as well, to draw in non-English speakers.
“Against all rigorous scientific thinking”
The stakes are high for diversifying Alzheimer’s research and getting more Latino Americans involved.
Without their participation, Aranda says, it becomes hard to tell whether a drug actually works for this population — and that is a huge public health priority, considering they make up the highest-risk groups in the country.
“We’re calling to action people to test this framework
to see if it has robustness [in how it targets]
the inclusion of underrepresented groups.”
The other issue is that drugs might have different side effects in certain groups. For example, a drug that has high risk of dangerous side effects in white participants might be safer for Latinos. Different genetic backgrounds give different people — and different racial groups — different vulnerabilities… and differing levels of protection.
“We’re calling to action people to test this framework,” Aranda said, “to see if it has robustness [in how it targets] the inclusion of underrepresented groups.” With a new framework, she and her colleagues see a new future for Latinos — one with more treatment options for people living with Alzheimer’s — and more understanding about how the disease can be prevented.