Recommendations to address key recruitment challenges of Alzheimer's disease clinical trials

Abstract

Clinical trials for Alzheimer's disease (AD) are slower to enroll study participants, take longer to complete, and are more expensive than trials in most other therapeutic areas. The recruitment and retention of a large number of qualified, diverse volunteers to participate in clinical research studies remain among the key barriers to the successful completion of AD clinical trials. An advisory panel of experts from academia, patient‐advocacy organizations, philanthropy, non‐profit, government, and industry convened in 2020 to assess the critical challenges facing recruitment in Alzheimer's clinical trials and develop a set of recommendations to overcome them. This paper briefly reviews existing challenges in AD clinical research and discusses the feasibility and implications of the panel's recommendations for actionable and inclusive solutions to accelerate the development of novel therapies for AD.

A call to address structural barriers to Hispanic/Latino representation in clinical trials on Alzheimer's disease and related dementias: A micro‐meso‐macro perspective

“…21 However, the NIH has systematically awarded scientists with federal grant funding resulting in limited evidence to inform AD/ADRD among the Latino population, as well as other racial and ethnic groups. 22 The rationale to diversify cohorts and address AD/ADRD health disparities is predicated on sound and rigorous scientific principles, 5,18,23,24 in order to (1) safeguard ethical research principles such as justice, beneficence, and respect for persons; (2) elucidate heterogeneity in causal mechanisms and responses to treatments and care; (3) create robust AD/ADRD estimates based on adequately powered studies including determinants of population-level differences; (4) enhance research designs and methods that address health equity considerations; (5) foster innovations in recruitment and retention; and (6) understand cultural and sociopolitical nuances in decision-making, help-seeking, and daily practices that impact health disparities.…”

“…The need to diversify AD/ADRD trial cohorts is critical and long overdue. Several calls to action have underscored the societal and scientific imperatives for diversifying trial cohorts 8,9,18–21 . In fact, several National Institutes of Health (NIH) scientific initiatives and strategies highlight the importance of increasing the representativeness of trial samples, including funding innovations in science on diversity, recruitment, and retention in aging research 21 .…”

Improved Prediction of Amyloid-β and Tau Burden Using Hippocampal Surface Multivariate Morphometry Statistics and Sparse Coding

“…Identifying a target group with a high frequency of Aβ/tau pathology may be aided by developing advanced computational models for identifying Aβ/tau pathology based on less intrusive, affordable, and accessible techniques. Specifically, emerging blood-based biomarkers (BBBM) [3][4][5] for AD brain pathology detection may lead to broader screening and enable early intervention [83,84]. Biomarker research supported by the Alzheimer's Drug Discovery Foundation's Diagnostic Accelerator led to an important milestone in 2020 when C2N diagnostic introduced the first commercially available biomarker blood test detecting brain amyloid plaque [85].…”

Differences in Motivators, Barriers, and Incentives between Black and White Older Adults for Participation in Alzheimer’s Disease Biomarker Research

“…During the process of recruiting both Black and White older adults, researchers need to explain to participants why these procedures are being conducted, what the procedure entails in appropriate detail, and provide opportunities to discuss safety concerns and risks. While education, information, and outreach appear to be necessary for successful recruitment strategies [3, 30, 31], participants also identified return of results as an important incentive for participation.…”