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

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. In clinic, participants were asked to complete motor and cognitive tasks on an Apple Watch and iPhone, and wear inertial sensors while performing the MDS-UPDRS Part III assessment. At home, participants completed mobile assessments twice monthly and wore an Apple Watch daily for at least one-week after every in person visit.

Results: We enrolled 132 individuals (82 PD and 50 control) across 17 sites between July 2019 and December 2021.  The proportion of time with tremor as assessed by the smartwatch was higher in those with PD (15.9% [16.3] of time recorded) compared to controls (0.6% [0.5]; P<0.001).  PD participants performed worse on cognitive tests on a mobile device including Trails A (30.0 [13.0] seconds compared to 30.5 [31.1] seconds; P<0.05), and DSMT (19 [6.5] correct versus 21.4 [5.7] correct; P>0.05). Speech of PD participants was more monopitch (during reading, pitch range in semitones was 4.7 [1.1] in PD vs 5.5 [1.3] in controls; P<0.001).  When performing a finger-tapping task on the mobile device, individuals with PD had greater variation across taps in their dominant (52.4 [45.4 ]% vs 32.4 [12.5]%; P <0.001) and non-dominant hand (51.1 [31.8 ]% vs 37.1 [12.7]%; P <0.001) compared to controls. We will also report on the longitudinal results across the 12-month study period from at-home and in clinic motor, speech, and cognitive tasks.

Conclusion: The WATCH-PD trial is one of the first multi-center, prospective, longitudinal digital markers studies in early PD patients. 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-baseline-phenotype-and-longitudinal-digital-assessments-in-early-pd/