Fusing Imaging & Digital Biomarkers: Building Regulator-Ready Multimodal Endpoints for Alzheimer’s, ALS & Rare CNS Trials
2:00 pm - Wednesday 2nd December 2026
- Moving beyond single-modality endpoints by integrating structural and functional neuroimaging (MRI, PET) with remote digital biomarkers (EEG, actigraphy, speech and cognitive sensors) to better capture neurodegenerative disease biology and treatment response
- Building a regulator-facing multimodal endpoint framework through practical harmonisation of imaging and digital biomarker platforms, with cross-validation against fluid biomarkers such as p tau217 and NfL to strengthen biological plausibility and regulatory confidence
- Applying lessons from Phase IIb/III Alzheimer’s programmes, EMA CHMP/ SAG-Neurology engagement, and ALS and rare disease trials to improve patient stratification, reduce screen failures, and create actionable endpoint strategies across AD, ALS, PD, and rare CNS indications
