Preliminary Schedule and Agenda

Clinical trials of disease-modifying therapies (DMTs) for Parkinson’s disease continue to rely heavily on the MDS-UPDRS Part III as a primary clinical endpoint, despite growing concern that conventional rating scales may lack the sensitivity needed to detect subtle treatment effects—particularly in early-stage populations where intervention may matter most. Against a backdrop of repeated challenges in PD DMT development, this workshop asks a central question for sponsors: are conventional clinical scales alone sufficient to evaluate disease modification?

This session will examine emerging evidence that digitally derived measures (DDMs) can capture PD progression with greater sensitivity than traditional rating scales, drawing on data from longitudinal at-home monitoring and composite measures derived from wearable sensors. Faculty will discuss how continuous measures of walking, non-walking behavior, motor fluctuation, and real-world activity may provide a richer and more responsive view of disease progression than periodic in-clinic assessment alone.

Through expert presentations, interactive roundtables, and moderated debate, participants will explore the scientific, operational, statistical, and regulatory considerations that will determine whether DDMs can be used confidently in PD DMT trials. Discussion will address effect-size and sample-size implications, patient compliance and remote data collection requirements, endpoint interpretability, and the level of evidence needed to support regulatory acceptance or formal qualification.

The workshop will conclude with a practical call to action for sponsors, researchers, regulators, and technology developers to align on evidence standards, validation pathways, and collaborative studies that can move DDMs from promising exploratory tools to fit-for-purpose endpoints—helping accelerate PD DMT development and increasing the likelihood that trials can detect meaningful treatment effects.

4:35 PM → 4:50 PM

Presentation Title To Be Announced

Speaker TBA
Institution

4:50 PM → 5:05 PM

Presentation Title To Be Announced

Speaker TBA
Institution

• Gap Mapping: What we need to know?
• Evidence Generation: How do we get there in the next 3-5 years?
• Concluding discussion and formulation of action plan

Please join us for the official ActiGraph Digital Data Summit 2025 kick off with refreshments and hors d'oeuvres. Early event check-in will be available till 8:00 PM.

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