Ethical challenges in the clinical translation of anti-amyloid monoclonal antibodies for Alzheimer’s disease: a scoping review

Background The development and evaluation of anti-amyloid beta monoclonal antibodies (mAbs) for the treatment of Alzheimer’s disease have been accompanied by extensive ethical debate spanning clinical trials, regulatory processes, prescribing practices, and healthcare delivery. This scoping review examined literature published between 2006 and 2026 to identify and clarify the landscape of ethical considerations surrounding the implementation, prescribing, and delivery of anti-amyloid mAbs across both research and clinical settings. Methods We searched PubMed, Scopus, Web of Science, Embase, and Ovid EBM Reviews (including CENTRAL and CDSR) from 2006 to March 2026 using a structured search strategy. Eligible publications focused on ethical issues associated with the clinical translation of anti-amyloid mAbs. Two reviewers independently screened titles, abstracts, and full-text articles, with duplicate extraction performed on an initial subset of publications. The review was conducted using JBI guidance and reported according to PRISMA-ScR. Results We identified 84 publications from 23 countries published between 2014 and 2026, including 12 original research studies, 1 systematic review, and 71 commentaries, narrative reviews, legal analyses, or practice guidelines. Analysis identified 32 subthemes, which were synthesized into 7 overarching themes: (1) beneficence and nonmaleficence, (2) respect for persons, (3) equity and accessibility, (4) evidence and trial integrity, (5) governance and stewardship, (6) relational and social impacts, and (7) health system readiness and sustainability. Among the 32 subthemes, uncertain clinical benefit and risk of harm (both within the beneficence and nonmaleficence theme) were discussed most frequently within the literature, each appearing in 61 publications. Conclusions The biomedical literature documents a broad range of ethical considerations relating to anti-amyloid mAbs. Despite this growing literature, it is primarily based on commentary, with few empirical studies, and even fewer incorporating the perspectives of patients, families, and clinicians. Doing so may add further context and nuance to ethical discussion about mAbs in the years ahead.