Potential implications of practice effects in Alzheimer's disease prevention trials.

ABSTRACT:

Introduction

Practice effects (PEs) present a potential confound in clinical trials with cognitive outcomes. A single-blind placebo run-in design, with repeated cognitive outcome assessments before randomization to treatment, can minimize effects of practice on trial outcome.

Methods

We investigated the potential implications of PEs in Alzheimer's disease prevention trials using placebo arm data from the Alzheimer's Disease Cooperative Study donepezil/vitamin E trial in mild cognitive impairment. Frequent ADAS-Cog measurements early in the trial allowed us to compare two competing trial designs: a 19-month trial with randomization after initial assessment, versus a 15-month trial with a 4-month single-blind placebo run-in and randomization after the second administration of

SUBMITTER: Jacobs DM 

PROVIDER: S-EPMC5671629 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature