Objective: To provide a longitudinal profile of early Parkinson’s disease (PD) progression using clinical and digital measures, and to evaluate the extent to which digital measures can more reliably characterize progression.

Background: The infrequent, variable nature of clinical assessments drives the need for large sample sizes and extended trial durations. Digital technologies can obtain more objective and frequent assessments of motor and non-motor function. The ability of sensor-derived and mobile measures to monitor progression in early PD is unknown.

Method: WATCH-PD is an observational study modelled on a disease-modifying, proof-of-concept trial in PD, integrating standard clinical assessments with novel digital tools that objectively measure motor and cognitive function over 12 months. Individuals with early PD (≤ 2 years since diagnosis, Hoehn & Yahr ≤ II) and age-matched controls participated. In clinic, participants were asked to complete motor and cognitive tasks on a smartwatch and smartphone and wear inertial sensors while performing the MDS-UPDRS Part III assessment. At home, participants completed mobile assessments twice monthly and wore a smart watch daily for at least one-week after every in person visit. Longitudinal changes in digital measures were analyzed using mixed models that included fixed effects for group, visit, baseline value, the interaction of group with visit, and random intercepts and slopes by participant.

Results: We enrolled 132 individuals (82 PD and 50 control) across 17 sites between July 2019 and December 2021. Rest tremor (measured from the smartwatch) increased and arm swing range of motion (from the smartwatch or research grade sensors) decreased over the 12 month study period and were significantly associated with disease duration (p<0.05). Interestingly, a subgroup of PD participants had minimal tremor at baseline and no significant progression over time.  Preliminary results suggest that other digital measures exhibit group differences but have minimal progression over time.

Conclusion: The WATCH-PD trial is one of the first multi-center, prospective, longitudinal digital markers studies in early PD. Longitudinal data contributes to the growing literature on the utility of digital technologies in clinical trials and their potential as sensitive measures of disease progression.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/watch-pd-longitudinal-digital-assessments-in-early-parkinsons-disease/