Objective: To describe the baseline characteristics of Parkinson’s disease (PD) clinical trial participants enrolled in a remote, long-term observational follow-up study.

Background: Participation in clinical research studies is cumbersome and assessments are often restricted to infrequent and time-consuming, in-clinic observation. Mobile and remote technologies may reduce participant burden, permit objective assessment in the home and result in new digital biomarkers of disease progression.

Method: Participants from two completed phase 3 clinical trials of potential disease-modifying therapeutics (SURE-PD3 and STEADY-PDIII) enrolled into AT-HOME PD. This 24-month observational study remotely characterizes long-term clinical outcomes through annual virtual research visits with a remote specialist. Optionally, participants complete quarterly two-week bursts of smartphone-based motor tasks and may opt into passive collection of GPS-based data (mPower). Additionally, participants may enroll in an online companion study, Fox Insight, and complete quarterly participant-reported outcome measures. In a sub-study, we are enrolling up to fifty individuals with PD from a separate on-going, longitudinal, observational study. Sub-study participants complete a single virtual research visit, which will establish the cross-sectional reliability of in-clinic versus virtual assessments (MoCA and MDS-UPDRS).

Results: From the two clinical trials, 350 individuals were pre-screened and 226 completed a baseline visit for AT-HOME PD (mean age (SD) of 64.3 (8.8) years, 39.8% female, 94% white) with participants located in 42 states and Canada. Of the optional study components, 72% of participants enrolled in Fox Insight and 81% in mPower. As of February 25, 2020, 12,714 smartphone-based motor tasks (mean (SD) 71.8 (74)/participant) have been completed with 57 individuals contributing passively collected data. The cohort has a mean (SD) modified MDS-UPDRS (AHPD-U01NS107009) part III score of 24.93 (11.50), Hoehn & Yahr of 1.79 (0.44), Schwab and England of 90.1% (5.6%), and MoCA score of 28 (1.9). Baseline virtual research visits were met with 97% satisfaction.

Conclusion: We successfully enrolled 45% of potentially eligible participants from the parent study cohorts into this long-term remote follow-up study, establishing the infrastructure for a new research model that is well accepted by participants.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/baseline-results-of-a-virtual-longitudinal-observational-study-of-parkinsons-disease-the-at-home-pd-cohort/