INTRODUCTION: To generalize safety and efficacy findings, it is essential that diverse populations are well represented in Alzheimer's disease (AD) drug trials. In this review, we aimed to investigate participant diversity in disease-modifying AD trials over time, and the frequencies of participant eligibility criteria.
METHODS: A systematic review was performed using Medline, Embase, the Cochrane Library, and Clinicaltrials.gov, identifying 2247 records.
RESULTS: In the 101 included AD trials, participants were predominantly White (median percentage: 94.7%, interquartile range: 81.0-96.7%); and this percentage showed no significant increase or decrease over time (2001-2019). Eligibility criteria such as exclusion of persons with psychiatric illness (78.2%), cardiovascular disease (71.3%) and cerebrovascular disease (68.3%), obligated caregiver attendance (80.2%), and specific Mini-Mental State Examination scores (90.1%; no significant increase/decrease over time) may have led to a disproportionate exclusion of ethnoracially diverse individuals.
DISCUSSION: Ethnoracially diverse participants continue to be underrepresented in AD clinical trials. Several recommendations are provided to broaden eligibility criteria.
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SF and JMP report a grant from The Netherlands Organisation for Health Research and Development/Alzheimer Nederland (ZonMw Memorabel; grant number 733050834). JES reports a personal James B. Reynolds scholarship for foreign study. LSS reports a grant from NIH (P30 AG066530). GMB reports grants from NIH/NIA (R01AG068183, R01AG067428, A2021142S) and the BrightFocus Foundation (A2021142S). MRM is supported by grants from the NIA/NIH (R13 AG071313-01, R01AG065110-01A1, NIH/NIA 5U19AG024904-14, NIH/NIA R01AG066471-01A1), NIH/NIMH (U24MH100931-03), NIH/NIA (5R24AG065163), National Science Foundation, the Genentech Health Equity 2020 Fund (G-89294), and the Alzheimer's Association (AARGD-16-446038).
Franzen, Sanne; Smith, Jade Emily; van den Berg, Esther; Rivera Mindt, Monica; van Bruchem-Visser, Rozemarijn L.; Abner, Erin L.; Schneider, Lon S.; Prins, Niels D.; Babulal, Ganesh M.; and Papma, Janne M., "Diversity in Alzheimer's Disease Drug Trials: The Importance of Eligibility Criteria" (2021). Sanders-Brown Center on Aging Faculty Publications. 179.