Use of High-Frequency In-Home Monitoring Data May Reduce Sample Sizes Needed in Clinical Trials.

ABSTRACT:

Background

Trials in Alzheimer's disease are increasingly focusing on prevention in asymptomatic individuals. This poses a challenge in examining treatment effects since currently available approaches are often unable to detect cognitive and functional changes among asymptomatic individuals. Resultant small effect sizes require large sample sizes using biomarkers or secondary measures for randomized controlled trials (RCTs). Better assessment approaches and outcomes capable of capturing subtle changes during asymptomatic disease stages are needed.

Objective

We aimed to develop a new approach to track changes in functional outcomes by using individual-specific distributions (as opposed to group-norms) of unobtrusive continuously monitored in-home data. Our objective was to co

SUBMITTER: Dodge HH 

PROVIDER: S-EPMC4574479 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature