Objective: To evaluate longitudinal change in WATCH-PD digital measures in a remote extension study in order to maximize learnings and inform use of digital measures in future Parkinson’s disease (PD) clinical trials.

Background: Demonstrating that a treatment alters the trajectory of PD involves identifying a notable shift in the progression rate, typically measured by the MDS-UPDRS. Subjective and fluctuating characteristics of traditional scales necessitate sizable participant groups and prolonged trial periods. Exploring digital tools to capture objective, highly-granular evaluations of both motor and non-motor capacities is of interest; however, the initial 12-month timeframe of the WATCH-PD study may fall short of the anticipated duration required for disease-modifying therapy investigations. The WATCH-PD2 study will gather up to 60 months of patient data, leveraging a robust digital device data set.

Method: Participants with PD were recruited from the original WATCH-PD trial. Study visits are conducted remotely every 3 months. During each visit, participants perform specific tasks through the smartphone app (BrainBaseline™, Clinical Ink) while in their OFF state. Following each visit, participants are asked to complete the smartphone app daily in their OFF state and wear the smartwatch on their most affected wrist daily for 1 week. Every 6 months we also gather patient-reported outcomes and a remotely administered MDS-UPDRS. Additionally, a trunk-worn accelerometer (Axivity), is worn by participants for 1 week following the baseline and month 12 visits.

Results: Recruitment began in February 2023 and we enrolled 48 individuals (mean age 65.6; 41.7% female; mean disease duration 3.7 years [range 2.5-5.4]; 34 (70.8%) taking dopaminergic medication). To date, 47 individuals have completed 36 months of data collection since the start of the original WATCH-PD study with analysis of longitudinal change in digital measures over this period planned to begin soon.

Conclusion: The WATCH-PD2 study is a remote extension that builds upon the encouraging outcomes of the original WATCH-PD dataset. This is one of the longest digital measures studies in early PD and will inform the field as we search for more objective, precise, and patient-centric measures that allow for efficient and meaningful evaluation of future therapies.

« Back to 2024 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/watch-pd2-a-remote-extension-digital-measures-study-in-early-parkinsons-disease-study-design-and-status-update/