In:
Alzheimer's & Dementia, Wiley, Vol. 18, No. S10 ( 2022-12)
Abstract:
To generalize safety and efficacy findings, it is essential that diverse populations are well represented in global Alzheimer’s disease (AD) drug trials. In this review, we aimed to 1) investigate participant diversity in disease‐modifying AD trials over time, 2) identify which eligibility criteria were used and how they were defined, and 3) how the eligibility criteria may have affected participant diversity levels. Method A systematic review of amyloid and tau trials in Alzheimer’s disease was performed using Medline, Embase, the Cochrane Library, and Clinicaltrials.gov, identifying 2247 records. Result In the 101 included AD trials, participants were predominantly white (median percentage: 94.7%, IQR: 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 MMSE‐scores (90.1%; no significant increase/decrease over time, Fig. 1 ) may have led to a disproportionate exclusion of ethnoracially diverse individuals. Furthermore, many eligibility criteria—such as those describing diabetes, hepatic disease, and renal conditions—often were not well defined, or the cut‐offs varied considerably across studies. Conclusion Ethnoracially diverse participants continue to be underrepresented in AD clinical trials. Several recommendations will be provided, such as the use of internationally recognized clinical classifications and cut‐offs, inclusion of participants with specific medical conditions as long as they are medically stable, and flexibility in requirements regarding caregiver attendance. Furthermore, changes need to be considered to 1) the instruments used in trials (e.g. overreliance on MMSE) and 2) requirements regarding education, literacy, and language.
Type of Medium:
Online Resource
ISSN:
1552-5260
,
1552-5279
Language:
English
Publisher:
Wiley
Publication Date:
2022
detail.hit.zdb_id:
2201940-6
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