Diversity in Alzheimer's disease drug trials: Reflections on reporting and social construction of race

Abstract

CONFLICTS OF INTERESTRLvB-V, JES, ELA, GMB, JMP, EvdB have nothing to disclose (aside from the funding reported elsewhere). SF received support to attend meetings/conferences from Alzheimer Nederland and the Erasmus Trustfonds. She served as the executive committee member of the Cultural Diversity & Psychology commission of the Dutch Association of Psychologists and serves as executive committee member to the Diversity and Disparities PIA of ISTAART. NDP is consultant to Boehringer Ingelheim, Amylyx, and Aribio (payments made to his institution). He is co-PI of studies with EIP Pharma and Fuji Film Toyama Chemical. He serves on the DSMB of Abbvie's M15-566 trial (payment to his institution). He is CEO and co-owner of the Brain Research Center, the Netherlands. He is also on the scientific program committee of the Alzheimer's Association. LSS reports grants/contracts by Eisai, Eli Lilly, Roche/ Genentech, Biogen, Biohaven, Novartis, and Washington University/NIA-DIAN-TU paid to the institution. In addition, he reports

Recruiting a prospective community cohort to study Alzheimer's disease and structural and social determinants of health among adults racialized as Black: The ARCHES cohort

“…Furthermore, researchers must not use traumatic historical events to excuse their own lack of effort to improve trust and successfully recruit participants. With limited, accessible disease‐modifying treatments that include representative samples of Black people, 40 , 41 the need for additional research to slow down and eventually cure AD remains a top priority for research institutions. Prior work 42 has supported a multi‐pronged approach for RER with persons racialized as Black.…”

Improving generalizability and study design of Alzheimer's disease cohort studies in the United States by including under‐represented populations

“…These exclusion criteria include substance abuse, cerebrovascular disease including stroke, psychiatric conditions such as severe depression, and medical comorbidities, and together, they act to exclude the majority of older adults. [22][23][24] Higher rates of comorbidities in Black Americans and adults with low education 20 result in even greater exclusion from clinical studies. In a recent preliminary analysis, 25 we examined the exclusion rates of adults from under-represented communities based on the operationalized medical condition exclusion criteria of the A4 study using data from the Health and Retirement Study, 26 a representative population-based sample in the United States with linked Medicare administrative data.…”

“…Many studies of AD and other dementias, and almost all clinical trials, explicitly exclude people with comorbidities or on medications known to affect cognition. These exclusion criteria include substance abuse, cerebrovascular disease including stroke, psychiatric conditions such as severe depression, and medical comorbidities, and together, they act to exclude the majority of older adults 22‐24 . Higher rates of comorbidities in Black Americans and adults with low education 20 result in even greater exclusion from clinical studies.…”

A call for clinical trial globalization in Alzheimer's disease and related dementia

“…Globalization of ADRD trials is a seminal strategy to address context‐specific questions related to biological and non‐biological variations that exist across populations. Cross‐population differences may influence treatment response and frequency of adverse events in response to investigational products 11 . In addition, the results and applicability of trials conducted in high‐income countries (HICs) may not be immediately applicable to LMICs.…”

“…Cross-population differences may influence treatment response and frequency of adverse events in response to investigational products. 11 In addition, the results and applicability of trials conducted in high-income countries (HICs) may not be immediately applicable to LMICs. Reasons include unequal access to health care and differences in stage at disease diagnosis, structural and social determinants of health that deeply influence the affordability of the new interventions, and limitations in resources needed to administer and monitor the new interventions (e.g., additional expertise and structural resources).…”