The Phase 2 Endpoint Dilemma: Bridging Subjective Scales And Objective Measures In Neurodegenerative Trials
Phase 2 neurodegenerative studies often hinge on endpoints that are too blunt for early, slow-moving disease. Relying solely on ADAS‑Cog or MDS‑UPDRS can mask real change through rater variability, practice effects, and limited sensitivity. This on‑demand session breaks down when composite endpoints sharpen signal detection — and when they add noise, operational burden, or interpretability risk.
You’ll get practical approaches for building endpoint hierarchies that connect cognition, function, and biomarkers to mechanistic hypotheses while staying regulator-ready. Learn how natural history datasets and real‑world evidence can guide selection, calibration, and powering so meaningful change is detectable within typical Phase 2 timelines. If you’re making go/no‑go decisions for emerging therapies, these frameworks can help reduce uncertainty and improve confidence in what your data is truly showing. We also cover common pitfalls in mixing modalities, choosing anchors, and communicating composite results to sites, statisticians, and regulators with clear visuals.
Watch to refine your endpoint strategy.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.