Abstract
IntroductionAccurate estimates of cognitive and clinical decline rates are essential to the design of clinical trials in Alzheimer's disease (AD) dementia. MethodsTo investigate the trajectories of individuals enrolled in therapeutic trials in mild-to-moderate AD, we analyzed the placebo arm data from 20 clinical trials including over 4500 subjects. We analyzed decline as measured by two cognitive instruments, the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAScog) and the Mini-Mental State Examination, and one clinical rating scale, the Clinical Dementia Rating Sum of Boxes. ResultsTrajectories were generally similar across trials and nearly linear. Greater cognitive impairment at baseline, younger age, and greater education were associated with increased rate of cognitive decline. Effect sizes for the ADAScog were generated as a function of population characteristics. DiscussionThese data will inform the design of future studies of potential disease-modifying therapies for mild-to-moderate AD dementia.
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