The Anti-Amyloid Monoclonal Antibody Lecanemab: 16 Cautionary Notes

Kasper P. Kepp, Stefano L. Sensi, Kasper B. Johnsen, Jorge R. Barrio, Poul F. Høilund-Carlsen, Rachael L. Neve, Abass Alavi, Karl Herrup, George Perry, Nikolaos K. Robakis, Bryce Vissel, Alberto J. Espay

Research output: Contribution to journalReview articlepeer-review

10 Scopus citations

Abstract

After the CLARITY-AD clinical trial results of lecanemab were interpreted as positive, and supporting the amyloid hypothesis, the drug received accelerated Food and Drug Administration approval. However, we argue that benefits of lecanemab treatment are uncertain and may yield net harm for some patients, and that the data do not support the amyloid hypothesis. We note potential biases from inclusion, unblinding, dropouts, and other issues. Given substantial adverse effects and subgroup heterogeneity, we conclude that lecanemab's efficacy is not clinically meaningful, consistent with numerous analyses suggesting that amyloid-β and its derivatives are not the main causative agents of Alzheimer's disease dementia.

Original languageEnglish
Pages (from-to)497-507
Number of pages11
JournalJournal of Alzheimer's Disease
Volume94
Issue number2
DOIs
StatePublished - 2023

Keywords

  • Alzheimer's disease
  • amyloid-β
  • antibody
  • lecanemab
  • subgroup analysis

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