Interpretation of the Guidelines

Interpretation of clinical application recommendations for anti-Aβ monoclonal antibodies (2025 Edition)

  • ZHI Nan ,
  • GENG Jieli ,
  • CAO Wenwei ,
  • SONG Yaying ,
  • WANG Gang
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  • Department of Neurology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China

Received date: 2025-11-06

  Revised date: 2025-12-09

  Accepted date: 2026-01-06

  Online published: 2026-04-25

Abstract

The Clinical Application Recommendations for Anti-Aβ Monoclonal Antibodies (2025 Edition) systema-tically integrates Phase Ⅲ clinical trial data for aducanumab, lecanemab, and donanemab, referencing relevant drug labels, domestic real-world evidence, and clinical practice experience. With a focus on lecanemab and donanemab, it provides a comprehensive update to the 2024 edition. The recommendations provide detailed guidance on patient screening before treatment, treatment regimen evaluation, medication protocol standardization, adverse event monitoring, discontinuation criteria, and management of special populations, with significant progress in individualizing discontinuation criteria, specif-ying that lecanemab is recommended as an 18-month fixed course. For donanemab, the treatment completion criterion is defined as achieving a Centiloid value measured by amyloid-β positron emission tomography (Aβ-PET) that reaches a preset threshold, specifically a single Centiloid value ≤11 or two consecutive Centiloid values both in the range of 11-25. Regarding safety management, the recommendations further refine the stratified monitoring and management protocol for amyloid-related imaging abnormalities (ARIA) and establish precise risk management strategies for special populations, including patients on anticoagulant therapy and apolipoprotein E (APOE) ε4/ε4 homozygotes. Currently, the clinical application of anti-Aβ monoclonal antibodies still faces several key challenges. The integrated application system of multidimensional biomarkers has not yet been systematically established, which constrains the development of individualized treatment pathways. Meanwhile, real-world evidence on long-term medication use in the Chinese population remains insufficient, hindering the local optimization of treatment strategies and refined risk management. Future efforts should focus on strengthe-ning research in the above directions to promote the continuous development of anti-Aβ monoclonal antibody therapy from a standardized model toward individualized precision medicine based on biomarkers and clinical phenotypes.

Cite this article

ZHI Nan , GENG Jieli , CAO Wenwei , SONG Yaying , WANG Gang . Interpretation of clinical application recommendations for anti-Aβ monoclonal antibodies (2025 Edition)[J]. Journal of Diagnostics Concepts & Practice, 2026 , 25(02) : 148 -156 . DOI: 10.16150/j.1671-2870.2026.02.005

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