What should convince a clinician of disease modification in Alzheimer's disease clinical trials?
The recent publication of extension data from post-regulatory trials of amyloid-lowering antibody therapies, such as donanemab and lecanemab, requires clinicians to critically appraise trial designs and analyses in order to evaluate claims made by authors and sponsors of disease modification. This Perspective outlines the challenges with assessing claims of disease course modification, provides a framework for their evaluation, reviews the different trial designs and analytical approaches used to test or support them, and proposes a practical appraisal checklist for evaluating studies.
Authors
- Jemma Hazan (ORCID: https://orcid.org/0000-0002-7223-4768)
- Kathy Y. Liu (ORCID: https://orcid.org/0000-0002-7482-2758)
- Robert Howard
Institutions
- North East London NHS Foundation Trust (GB)
- University College London (GB)
Publication Details
- Journal
- Alzheimer s & Dementia
- Published
- 2026-07-01
- DOI
- https://doi.org/10.1002/alz.71643
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Alzheimer’s Research UK