The Evolution of Randomized Clinical Trial Designs to Assess Therapeutics in Alzheimer Disease

What are the major characteristics of randomized clinical trials (RCTs) for Alzheimer disease (AD), and how have these characteristics evolved?In this study of 203 RCTs with 79 589 participants, the mean sample size and trial duration increased over time, reflecting a shift from symptomatic treatments toward disease-modifying therapies earlier in the disease. Disease-modifying RCTs tended to be funded by the pharmaceutical industry.The findings of this study suggest that AD RCTs are now designed to detect smaller clinical differences, which emphasizes the need to define systematic tools to assess these interventions’ clinical meaningfulness.

Corresponding Authors: Etienne Aumont, PhD (etienne.aumont@mail.mcgill.ca), and Pedro Rosa-Neto, MD, PhD (pedro.rosa@mcgill.ca), Translational Neuroimaging Laboratory, Montreal Neurological Institute, 3801 University St, Montréal, QC H3A 2B4, Canada.

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