Objective: To summarize the design of the Parkinson’s Progression Markers Initiative (PPMI) Digital sub-study. The study objective is to identify the earliest signs and symptoms of Parkinson’s Disease (PD) and to determine how these change with time using remote, at-home assessments with a smartphone application.

Background: The PPMI is a longitudinal, observational, multi-center natural history study containing three main studies, i.e., PPMI Online, PPMI Remote, and PPMI Clinical, which aim to include 100,000 participants at-risk for or with overt PD and healthy volunteers [1]. All enrolled participants are eligible to participate in the PPMI Digital sub-study, in which a downloadable application for personal smartphones will be provided.

Method: The new downloadable application includes active tests and selected questionnaires. The active tests assessing tremor, rigidity, bradykinesia and postural stability are based on those in the Roche PD Mobile Application v2 [2]. Cognition will be assessed with three tasks of executive functioning and visuospatial working memory. Questionnaires will assess quality of life, motor symptom severity, and disease-specific health status. For PPMI Clinical participants, the schedule of assessments comprises circa half of the active tests which alternate daily. PPMI Online and PPMI Remote participants will receive a lightweight version of the schedule of assessment consisting of 1-2 active tests per day lasting 1-3 min per day.

Results: The study is ongoing; the application has been launched into the study in February 2022. Representative examples of digital data will be presented, along with interim acceptability and adherence data.

Conclusion: The downloadable smartphone application designed for the PPMI Digital sub-study has the potential to reach all 100,000 targeted participants, enabling the remote, continuous and objective assessment of PD signs. Along with all other PPMI data, the digital data will be made available to the community, empowering researchers around the world to incorporate digital biomarkers in their data analysis.

References: [1] Marek, K., Siderowf, A., Simuni, T., Chahine, L., Kieburtz, K., Mollenhauer, B., Galasko, D., Merchant, K., Brown, E., Coffey, C. and Dobkin, R., 2021, September. Parkinson Progression Marker Initiative-New Science/New Cohorts. In MOVEMENT DISORDERS (Vol. 36, pp. S187-S187). 111 RIVER ST, HOBOKEN 07030-5774, NJ USA: WILEY.

[2] Lipsmeier, F., Taylor, K.I., Postuma, R.B., Volkova-Volkmar, E., Kilchenmann, T., Mollenhauer, B., Bamdadian, A., Popp, W.L., Cheng, W.Y., Zhang, Y.P. and Wolf, D., 2021. Remote monitoring of progression in early Parkinson’s disease: reliability and validity of the Roche PD Mobile Application v2. medRxiv.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/remote-identification-of-early-sensor-based-markers-of-parkinsons-disease-using-participants-smartphones-the-parkinson-progression-marker-initiative-digital-sub-study/