PD Digital Biomarker Analytical Validity Study V1
Research type
Research Study
Full title
AN OBSERVATIONAL STUDY TO EVALUATE ANALYTICAL VALIDITY OF PDV3 SMARTPHONE-BASED ASSESSMENTS IN PARTICIPANTS WITH PARKINSON’S DISEASE AND IN HEALTHY CONTROLS
IRAS ID
353048
Contact name
Luis Matos
Contact email
Sponsor organisation
Roche Diagnostics International Ltd
Duration of Study in the UK
1 years, 8 months, 0 days
Research summary
This study aims to evaluate the analytical validity of a mobile application, used for monitoring the symptoms of persons living with Parkinson’s Disease (pwPD). This application assesses hand function, gait, balance, and speech through different active tasks. It also has the capability to assess activities of daily living through passive monitoring (when participants carry the phone with them while performing their usual activities during the day). This mobile application is a novel tool for measuring disease progression, aimed to be used as an endpoint in clinical trials to measure the effectiveness of novel treatments in a more sensitive, frequent, and objective way. Its outcome measures require extensive validation in order to be accepted as an endpoint in clinical trials. One of these validation steps is analytical validity, which evaluates whether a novel measurement tool actually measures what it is supposed to measure. To investigate this, in this study we will compare the outcomes of PDv3 against gold standard measurements, such as motion capture or research grade IMU sensors, in 60 pwPD and 20 Healthy Controls. We will also evaluate within-day and between-day reliability, as well as the perceived usefulness of the mobile application. The study participants will be asked to attend the Gait Laboratory at the Clinical Ageing Research Unit, Newcastle Biomedical Research Centre twice, first to get familiar with the mobile application, and then, after 28 days of performing the mobile assessments at home, to perform different tasks while being recorded using the gold standard measurement systems. The study is purely observational, does not involve any treatment or invasive procedures. The results of this study will be used to support future regulatory approvals to achieve an accepted endpoint for clinical trials. Using digital measures as endpoints would, in turn, enable faster, smaller, and thus less expensive clinical trials.
REC name
Wales REC 7
REC reference
25/WA/0062
Date of REC Opinion
3 Mar 2025
REC opinion
Favourable Opinion