Avoiding causal fraud in the evaluation of clinical benefits of treatments for Alzheimer's disease.

ABSTRACT: Recent regulatory approvals of three amyloid-lowering monoclonal antibody therapies for the treatment of Alzheimer's disease (AD) have triggered a polarizing debate in the field on the clinical meaningfulness of their reported effects. The question of how to define clinical meaningfulness for any treatment that has a modest effect size is important and will likely be subject to influence from interested stakeholders. We warn of claims of evaluating meaningful within-individual change from randomized parallel-group trials of AD treatments, sometimes purportedly assessed by a commonly recognized "responder" analysis approach, and explain why it is likely to mislead and should simply be avoided. The average between-group difference in score change is where the debate and research efforts shou

SUBMITTER: Liu KY 

PROVIDER: S-EPMC11851320 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature