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

• Published in: Parkinsonism & related disorders 2023-04, Vol.109, p.105355-105355, Article 105355
• Main Authors: Chen, Chen, Kowahl, Nathan R., Rainaldi, Erin, Burq, Maximilien, Munsie, Leanne M., Battioui, Chakib, Wang, Jian, Biglan, Kevin, Marks, William J., Kapur, Ritu
• Format: Article
• Language: English
• Subjects: Alzheimer Disease; Digital biomarkers in Parkinson's; Digital-based endpoints in Parkinson's; Humans; Lewy Body Disease - drug therapy; Parkinson Disease - diagnosis; Parkinson Disease - drug therapy; Pharmacodynamic response biomarkers in Parkinson's; Wearable sensors; Wrist
• ISSN: 1353-8020; 1873-5126
• DOI: 10.1016/j.parkreldis.2023.105355

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. 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. 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. Digital measurements detected treatment effects in a smaller cohort over a shorter period than conventional clinical assessments. clinicaltrials.gov, NCT03305809 •Digital measurements (DMs) can be incorporated in Lewy Body Dementia trials.•DMs (daily step count and ambulatory time) detected significant treatment effects.•Detection was in a smaller group, at an earlier time relative to clinical measures.•DMs may be more efficient than traditional clinical measures for therapy evaluation.