Introduction: There is increasing emphasis on the importance of optimizing and standardizing clinical trials of agitation in Alzheimer's disease (AD), but the risks of bias arising from published trials and the number and design of unpublished studies are poorly understood.
Methods: Using the ClinicalTrials.gov database, we systematically reviewed all registered investigational clinical trials for agitation in AD to describe the landscape of agitation drug treatment trials and to assess their quality and generalizability.
Results: We included 52 clinical studies registered over the past 25 years. Within published randomized controlled trials (RCTs), there was a high rate of participant dropout, poor reporting of randomization procedures, and inconsistent definitions of the sample included for analysis. There was also evidence of publication and funder bias.
Discussion: We discuss factors that limit the internal and external validity of published RCTs and make additional recommendations for the conduct and reporting of future clinical trials of agitation in AD.
Keywords: Alzheimer's disease; agitation; clinical trials; dementia; systematic review.
© 2021 The Authors. Alzheimer's & Dementia: Translational Research & Clinical Interventions published by Wiley Periodicals, Inc. on behalf of Alzheimer's Association.