Diversity in Alzheimer's disease drug trials: The importance of eligibility criteria

Sanne Franzen, Jade Emily Smith, Esther van den Berg, Monica Rivera Mindt, Rozemarijn L. van Bruchem-Visser, Erin L. Abner, Lon S. Schneider, Niels D. Prins, Ganesh M. Babulal, Janne M. Papma

Research output: Contribution to journalReview articlepeer-review

12 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)810-823
Number of pages14
JournalAlzheimer's and Dementia
Volume18
Issue number4
DOIs
StatePublished - Apr 2022

Bibliographical note

Funding Information:
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).

Funding Information:
The authors would like to thank Wichor Bramer from the Erasmus MC University Medical Center Rotterdam for his help in developing the search strategy and Jolien Franzen for her contribution to the results section. We also acknowledge the ABOARD consortium for supporting the work on diversity in primary and secondary prevention of Alzheimer’s disease in the Netherlands.

Publisher Copyright:
© 2021 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.

Keywords

  • clinical trial
  • clinical trial protocols
  • cultural diversity
  • ethnic groups
  • phase II
  • phase III
  • randomized controlled trials

ASJC Scopus subject areas

  • Epidemiology
  • Health Policy
  • Developmental Neuroscience
  • Clinical Neurology
  • Geriatrics and Gerontology
  • Cellular and Molecular Neuroscience
  • Psychiatry and Mental health

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