基于腕部佩戴式传感器的测量方法用于在路易体痴呆患者中进行小样本药物效果检测。

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

作者信息

Chen Chen, Kowahl Nathan R, Rainaldi Erin, Burq Maximilien, Munsie Leanne M, Battioui Chakib, Wang Jian, Biglan Kevin, Marks William J, Kapur Ritu

机构信息

Verily Life Sciences, 269 E Grand Ave, South San Francisco, CA, 94080, USA.

Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.

出版信息

Parkinsonism Relat Disord. 2023 Apr;109:105355. doi: 10.1016/j.parkreldis.2023.105355. Epub 2023 Mar 4.

DOI:10.1016/j.parkreldis.2023.105355

PMID:36905719

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.

摘要

引言

帕金森病（PD）的晚期临床试验中，很少有能证明基于传感器的日常生活活动数字测量对检测治疗反应的临床有效性的证据。本研究的目的是评估轻度至中度路易体痴呆患者的数字测量在一项随机2期试验中是否能显示出治疗效果。

方法

在一项为期12周的美维达伦试验（安慰剂对照，剂量分别为10、30或75毫克）中进行子研究，其中70/344名患者（与总体人群相似）佩戴了腕部多传感器设备。

结果

在整个研究队列中，第12周时通过传统临床评估（运动障碍协会统一帕金森病评定量表[MDS-UPDRS]第一至三部分总和以及阿尔茨海默病协作研究临床总体变化印象[ADCS-CGIC]评分）得出的治疗效果具有统计学意义，但在子研究中并非如此。然而，数字测量在子研究队列的第6周检测到显著效果，并持续到第12周。