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

Journal: Alzheimer's & dementia : the journal of the Alzheimer's Association

Volume: 18

Issue: 4

Year of Publication: 2022

Affiliated Institutions:  Department of Neurology, Erasmus MC University Medical Center, Rotterdam, the Netherlands. Department of Psychology and Latin American Latino Studies Institute, Fordham University, The Bronx, New York, USA. Department of Internal Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands. Sanders-Brown Center on Aging and Alzheimer's Disease Center, University of Kentucky, Lexington, Kentucky, USA. Keck School of Medicine of the University of Southern California, Los Angeles, California, USA. Alzheimer Center, Department of Neurology, VU University Medical Center, Amsterdam, the Netherlands. Department of Neurology and Knight Alzheimer's Disease Research Center, Washington University School of Medicine, St. Louis, Missouri, USA.

Abstract summary 

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.A systematic review was performed using Medline, Embase, the Cochrane Library, and Clinicaltrials.gov, identifying 2247 records.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.Ethnoracially diverse participants continue to be underrepresented in AD clinical trials. Several recommendations are provided to broaden eligibility criteria.

Authors & Co-authors:  Franzen Sanne S Smith Jade Emily JE van den Berg Esther E Rivera Mindt Monica M van Bruchem-Visser Rozemarijn L RL Abner Erin L EL Schneider Lon S LS Prins Niels D ND Babulal Ganesh M GM Papma Janne M JM

Study Outcome 

Source Link: Visit source

Statistics
Citations :  Alzheimer's Association . 2015 Alzheimer's disease facts and figures. Alzheimers Dement. 2015;11:324‐384.
Authors :  10
Identifiers
Doi : 10.1002/alz.12433
SSN : 1552-5279
Study Population
Male,Female
Mesh Terms
Alzheimer Disease
Other Terms
clinical trial;clinical trial protocols;cultural diversity;ethnic groups;phase II;phase III;randomized controlled trials
Study Design
Cross Sectional Study
Study Approach
Systemic Review
Country of Study
Publication Country
United States