Power analysis to detect treatment effects in longitudinal clinical trials for Alzheimer's disease.

ABSTRACT:

Introduction

Assessing cognitive and functional changes at the early stage of Alzheimer's disease (AD) and detecting treatment effects in clinical trials for early AD are challenging.

Methods

Under the assumption that transformed versions of the Mini-Mental State Examination, the Clinical Dementia Rating Scale-Sum of Boxes, and the Alzheimer's Disease Assessment Scale-Cognitive Subscale tests'/components' scores are from a multivariate linear mixed-effects model, we calculated the sample sizes required to detect treatment effects on the annual rates of change in these three components in clinical trials for participants with mild cognitive impairment.

Results

Our results suggest that a large number of participants would be required to detect a clinically meaningful tr

SUBMITTER: Huang Z 

PROVIDER: S-EPMC5590710 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature