Wrist-worn sensor-based measurements for drug effect detection with small samples in people with Lewy Body Dementia

Abstract

Introduction: Few late-stage clinical trials in Parkinson's disease (PD) have produced evidence on the clinical validity of sensor-based digital measurements of daily life activities to detect responses to treatment. The objective of this study was to assess whether digital measures from patients with mild-to-moderate Lewy Body Dementia demonstrate treatment effects during a randomized Phase 2 trial.

Methods: Substudy within a 12-week trial of mevidalen (placebo vs 10, 30, or 75 mg), where 70/344 patients (comparable to the overall population) wore a wrist-worn multi-sensor device.

Results: Treatment effects were statistically significant by conventional clinical assessments (Movement Disorder Society-Unified Parkinson's Disease Rating Scale [MDS-UPDRS] sum of Parts I-III and Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change [ADCS-CGIC] scores) in the full study cohort at Week 12, but not in the substudy. However, digital measurements detected significant effects in the substudy cohort at week 6, persisting to week 12.

Conclusions: Digital measurements detected treatment effects in a smaller cohort over a shorter period than conventional clinical assessments.

Trial registration: clinicaltrials.gov, NCT03305809.

Keywords: Digital biomarkers in Parkinson's; Digital-based endpoints in Parkinson's; Pharmacodynamic response biomarkers in Parkinson's; Wearable sensors.