Objective:

To communicate preliminary results of a study to understand real-world feasibility of digital health technologies (DHTs) to capture Parkinson’s disease (PD) symptoms and progression.

Background:

Evaluating treatment effects in PD relies on point-in-time clinical assessments that are susceptible to rater bias and the fluctuating nature of the disease itself. Passive monitoring by DHTs such as the Rune Labs Kinematic System, which tracks wrist movements detected by an Apple Watch or iPhone, and the Emerald Device, which uses radio waves to wirelessly monitor movements, can objectively and continuously capture real-world function to create detailed presentations of daily function.

Design/Methods:

Participants in this global, multicenter, noninterventional study (NCT05363046) are people with clinically established PD aged ≥39 to ≤70 years receiving standard-of-care treatment that does not adequately control symptoms. The primary objective is to assess the impact of the frequency of PD diary assessments over time, including reliability and compliance. A subgroup of approximately 50 US participants is undergoing real-world monitoring with DHTs. The feasibility and reliability of DHTs to capture continuous measures of symptoms and disease progression are being assessed as exploratory objectives. DHT feasibility has been evaluated at Month 6 with a DHT satisfaction questionnaire. All analyses are descriptive in nature.

Results:

As of 10/1/2024, 194 participants were randomized in the main study. Participants in the DHT subgroup (n=47) were a mean (SD) age of 61.3 (6.3) years and mostly male (74.5%) and White (89.4%), with a Hoen and Yahr score of 2 in the ON state (80.9%) at baseline; mean (SD) time since PD diagnosis was 5.9 (1.9) years. DHT satisfaction as well as preliminary data from Rune and Emerald devices will be presented.

Conclusions:

Comprehensive data generated by this noninterventional study will further our understanding of the real-world feasibility of using DHTs as objective measures of PD symptoms and progression.