Composite cognitive and functional measures for early stage Alzheimer's disease trials.

ABSTRACT:

Introduction

Composite scales have been advanced as primary outcomes in early stage Alzheimer's disease trials, and endorsed by the U.S. Food and Drug Administration (FDA) for pivotal trials. They are generally composed of several neurocognitive subscales and may include clinical and functional activity scales.

Methods

We summarized the development of 12 composite scales intended as outcomes for clinical trials and assessed their characteristics.

Results

Composite scales have been constructed from past observational and clinical trial databases by selecting components of individual neuropsychological tests previously used in clinical trials. The atheoretical approaches to combining scales into a composite scale that have often been used risk omitting clinically import

SUBMITTER: Schneider LS 

PROVIDER: S-EPMC7233425 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature