Parkinsonism & related disorders · 2023
Wrist-worn sensor-based measurements for drug effect detection with small samples in people with Lewy Body Dementia.
Клиническое исследование II фазыРандомизированное исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Chen Chen, Kowahl Nathan R, Rainaldi Erin, Burq Maximilien, Munsie Leanne M, Battioui Chakib, Wang Jian, Biglan Kevin, Marks William J, Kapur Ritu
Аннотация
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.
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.