Objective: To describe the change in characteristics of Parkinson’s disease (PD) clinical trial participants over 24 months following trial participation in a remote, longitudinal observational follow-up study.

Background: Remote longitudinal follow up of individuals with PD who have completed participation in a clinical trial can facilitate better characterization of disease progression as well as the mid- to long-term assessment of the effects of experimental therapeutics. We enrolled participants from two completed phase 3 clinical trials of potential disease-modifying therapeutics (SURE-PD3 and STEADY-PDIII) to complete a 24-month remote observational study.

Method: Enrolled participants completed annual virtual research visits with a movement disorder specialist. During screening, an investigator reviewed health history and concomitant medications, and recorded changes at subsequent visits. Additional outcome measures collected annually included the Montreal Cognitive Assessment (MoCA), and Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), modified for remote administration. Participants could optionally consent to use of a smartphone application and to complete routine, longitudinal patient-reported outcome surveys through a separate online clinical study, Fox Insight.

Results: Of 226 participants enrolled from 42 states in the US and Canada, 200 (88%) completed a Month 24 visit (mean age (SD) of 67 (8.5) years, 39% female, 93% white/non-Hispanic). At Month 24, mean (SD, range) time since diagnosis was 5.8 (1.2, 3.3 to 9.2) years. Mean (SD) MDS-UPDRS motor score increased by 5.8 (12.0) from 24.5 (11.0) at baseline to 30.4 (12.4) at Month 24, and MoCA scores were unchanged at 28.2 (2.1) at Month 24. The proportion of participants on levodopa increased from 73% (n = 164) at baseline to 92% (n = 184) at Month 24. Among those on levodopa, the proportion reporting dyskinesias increased from 23% at baseline to 34% at month 24 and OFF time from 52% to 63%.

Conclusion: We have successfully demonstrated the feasibility of remotely following and clinically characterizing a clinical trial cohort over two years. Analyses of change in smartphone-based digital measures may reveal more about the progression of disease in this cohort.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/month-24-results-of-a-virtual-longitudinal-observational-study-of-parkinsons-disease-the-at-home-pd-cohort/