Despite a significantly higher risk, Hispanic/Latinx Americans are underrepresented in clinical trials of Alzheimer’s disease and related dementias (ADRD), prompting an “urgent” call to action to address the problem.

“In this new era of approved treatments for Alzheimer’s, the need to diversify clinical trial cohorts is critical and long overdue,” Carl Hill, PhD, MPH, Alzheimer’s Association chief diversity officer and an author on the report, said in a news release.

“We must ensure that treatments are safe and effective for individuals who are disproportionately affected and underserved, and the same need is there for proper representation of these communities in research on risk factors, diagnosis, care, prevention, and all other dementia science topics,” Hill said.

The report was published online June 14 in Alzheimer’s & Dementia: Translational Research & Clinical Interventions.

Closing the Gap  

Hispanic/Latinx persons are the largest minoritized racial/ethnic group in the US, comprising 19% of the population. Older Latinx persons are about 1.5 times as likely to have ADRD as older Whites and are predicted to experience an 832% increase in rates by 2060, the authors write.

Yet, of the more 200 ADRD clinical trials being conducted with more than 70,000 Americans, Latinx individuals make up only a small fraction of participants, the authors note.

“Most of the clinical trials and even observational research studies in the area of memory, dementia and Alzheimer’s disease, etc, have excluded a big swath of our population,” first author María Aranda, PhD, MSW, with University of Southern California Alzheimer’s Disease Research Center, Los Angeles, told Medscape Medical News. 

Closing the huge gap in Latinx enrollment in ADRD trials “just makes scientific sense,” Aranda said.

“Especially in trials testing new drugs to mitigate the effect of dementia.” Hispanic/Latinx underrepresentation “means that we don’t know if those drugs or agents work the same way across the board and their potential side effects is these populations,” she noted.

The authors propose a novel “Micro-Meso-Macro” framework that focuses on reducing multilevel barriers and their negative impact on US Latinx recruitment into Alzheimer’s clinical trials.

The framework has an enhanced focus on institutional (meso-level) and policy (macro-level) dimensions.

According to the authors, current efforts to engage and recruit Latinx Americans into ADRD trials typically address individual- and family-level (micro) factors such as language, cultural beliefs, knowledge of aging and memory loss, and logistical and travel considerations.

This results in diminished attention to upstream institutional- and policy-level barriers, where decisions around policies and funding are ultimately made.

“Structural obstacles are more potent and impactful than individual or family obstacles and have more significant and long-lasting influence on the representation of Latinos in Alzheimer’s research,” Aranda said in a news release.

Bold Strategies Needed

The group makes several recommendations. One is to make binding all diversity plans at the US Food and Drug Administration (FDA) for ADRD clinical trials. 

As previously reported by Medscape Medical News, in draft guidance, the FDA recommends medical companies submit a “race and ethnic diversity plan” to the FDA during the early stages of clinical development.

Inspired by the FDA’s diversity plans, the group also calls on the National Institutes of Health (NIH) to continue to require diversity plans of all clinical trialists applying for funding, and continuing renewals.

“Trials get funded and refunded yet they continue to use exclusionary practices. It’s not that I think that people are doing this maliciously or on purpose. I think it just doesn’t occur to them and at the end of the day that’s a problem,” Aranda told Medscape Medical News.

Other key recommendations include:

• Calling on pharmaceutical partners and clinical research organizations to address structural factors that inhibit Latinx representation in ADRD clinical trials.

• Shifting to (and embedding) trial operations within Latinx communities and settings.

• Focusing on Latinx participants’ healthcare needs and preferences for information.

• Creatively address limited literacy in English and Spanish.

• Requiring information on sample representativeness when a trial’s findings are reported.

• Expanding research initiatives to include diverse cohorts and etiologies related to cognitive health based on what matters most to Latinx persons.

• Supporting national legislation promoting trial participation of underrepresented groups.

Looking at the big picture, the group note that clinical trials will “one day lead our nation toward finding a cure or prevention for AD/ADRD, thereby eliminating the human and societal toll — a benefit that should be equally and equitably distributed across population groups.”

“Our goal is to accelerate the representation of the Latino population and other underrepresented groups in AD/ADRD trials – and doing so with clear guidelines and bold strategies that respect people’s lived experience,” they write.

Funding for this work was provided by the National Institute on Aging (NIA). Aranda reports no relevant financial relationships. Hill is an employee of the Alzheimer’s Association.

Alzheimer’s Dement Transl Res Clin Interv. Published online June 14, 2023. Full text

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