Novel Endpoints in Parkinson's Trials: Wearables, AI, and Digital Biomarkers

 Parkinson's disease research has long relied on established clinician-rated assessments like the UPDRS that have successfully supported drug approvals. Yet these traditional tools capture only brief snapshots during clinic visits, missing the motor fluctuations, dyskinesias, freezing of gait episodes, and ON/OFF states that patients experience throughout their daily lives. Meanwhile, patient diaries prove subjective and unreliable, with patients unable to accurately differentiate between specific symptoms or recall experiences objectively. How can sponsors capture real-world disease manifestations that traditional endpoints miss?

 

Dr. Lew Fredane, Clinical Vice President and Therapeutic Area Leader for Neurology at Signant Health, explores the emerging landscape of novel endpoints in Parkinson's trials. With over 15 years in drug development and clinical practice as a neurologist, Dr. Fredane examines how wearable sensors, artificial intelligence, remote assessment technologies, and digital biomarkers are transforming PD research.

Key innovations explored:

• Wearable inertial measurement units (IMUs) that continuously monitor bradykinesia, dyskinesia, tremor, and gait disturbances in home environments
• AI-driven video analysis systems that capture simplified motor exam components for algorithmic assessment of movement quality
• Voice analysis software capable of detecting early PD signs before physical symptoms manifest
• Integration strategies for combining traditional clinician assessments with objective sensor-derived endpoints
• Regulatory considerations and validation requirements for novel digital measures in clinical trials

Watch below to learn about innovations in trial design for Parkinson's disease research.