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.

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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

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article

What should convince a clinician of disease modification in Alzheimer's disease clinical trials?

Jemma Hazan, Kathy Y. Liu, Robert Howard
Alzheimer s & Dementia
Statistical Methods in Clinical Trials
article

What should convince a clinician of disease modification in Alzheimer's disease clinical trials?

Jemma Hazan, Kathy Y. Liu, Robert Howard
article en

Abstract

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.

Alzheimer s & DementiaVol. 22(7)
North East London NHS Foundation Trust (GB), University College London (GB)
Alzheimer’s Research UK
Openalex Percentile: Top 5%
Statistical Methods in Clinical Trials
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