Beyond A Single Study Visit: Lesson Learned from the AD Clinical Trials
Disease-modifying treatments often show early and consistent effects throughout trials. Analytical models that leverage these characteristics can significantly reduce sample size. Future clinical trials could accelerate treatment development by adopting models that utilize multiple visits as the primary analysis while retaining MMRM-Last-Visit for sensitivity analysis. Under a disease-modifying treatment, the estimated disease progression patterns from the primary and sensitivity analysis models are expected to align consistently.
Authors
- Paul Delmar (ORCID: https://orcid.org/0000-0002-2095-6283)
- Jinglin Zhong
- Guoqiao Wang
- David Li
Institutions
- Roche (Switzerland) (CH)
- Washington University in St. Louis (US)
- Eisai (United States) (US)
- Alector (United States) (US)
Publication Details
- Journal
- Alzheimer s & Dementia
- Published
- 2025-12-01
- DOI
- https://doi.org/10.1002/alz70859_099570
- Primary Topic
- Statistical Methods and Bayesian Inference
- Type
- article
- Field-Weighted Citation Impact
- 0.00