Objective: To determine whether digital measures can provide a progression profile in early Parkinson’s disease (PD) that is more sensitive and/or less variable than current clinical trial standards.

Background: Establishing that a treatment modifies the course of PD requires observing significant change in rate of progression as currently measured by the UPDRS. The subjective and variable nature of the UPDRS drives large sample sizes and extended trial durations. The periodic nature of the UPDRS assessment implies that fluctuations in symptoms are not adequately captured. Using digital technologies to obtain objective, frequent and high-granularity assessments of motor and non-motor function is therefore of interest. However, the ability of these devices to monitor progression in early PD is not yet known.

Method: WATCH-PD is modelled on a disease-modifying proof-of-concept trial in de novo PD, and incorporates standard clinical and imaging markers of progression with novel digital tools that objectively measure motor and cognitive function in and out of the clinic. The study is conducted at 20 Parkinson Study Group (PSG) sites in the US. We intend to enroll 100 untreated PD patients within 2 years of diagnosis (H&Y ≤ II) in a 12-month study. DaT imaging is used for diagnostic confirmation, and a second scan is collected at 12 months to assess progression. In clinic, participants wear a set of inertial sensors (APDM Mobility Lab), an Apple Watch and an iPhone while performing motor tasks including the UPDRS III, allowing collection of objective kinematic signals. At home, participants use an Apple Watch and iPhone to complete an instrumented motor and cognitive battery. Participants complete QoL/ADL questionnaires at each visit.

Results: To date, 23 individuals have enrolled and completed a baseline visit. Baseline associations between objective digital measures of gait, tremor, and cognition will be examined with respect to clinical exams measuring associated constructs (e.g., UPDRS III, MoCA), and examining associations between digital measures and patient-reported quality of life and ability to complete activities of daily living.

Conclusion: The WATCH-PD trial is one of the first large, prospective, longitudinal digital markers studies in untreated early PD patients, and may provide useful information regarding the utility of wearable and mobile devices for measuring functional outcomes in clinical trials.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/watch-pd-wearable-assessments-in-the-clinic-and-home-in-parkinsons-disease-study-design-and-update/