Impacts on study design when implementing digital measures in Parkinson's disease-modifying therapy trials.

ABSTRACT:

Introduction

Parkinson's Disease affects over 8.5 million people and there are currently no medications approved to treat underlying disease. Clinical trials for disease modifying therapies (DMT) are hampered by a lack of sufficiently sensitive measures to detect treatment effect. Reliable digital assessments of motor function allow for frequent at-home measurements that may be able to sensitively detect disease progression.

Methods

Here, we estimate the test-retest reliability of a suite of at-home motor measures derived from raw triaxial accelerometry data collected from 44 participants (21 with confirmed PD) and use the estimates to simulate digital measures in DMT trials. We consider three schedules of assessments and fit linear mixed models to the simulated data to dete

SUBMITTER: Lavine JS 

PROVIDER: S-EPMC11496294 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature