{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T16:16:28Z","timestamp":1777392988923,"version":"3.51.4"},"reference-count":16,"publisher":"SAGE Publications","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAD"],"published-print":{"date-parts":[[2024,10,8]]},"abstract":"<jats:p>Anti-amyloid drugs for early Alzheimer\u2019s disease, including lecanemab, are associated with adverse events (AEs), such as amyloid-related imaging abnormalities (ARIA)-edema\/effusion (E), ARIA-hemorrhage, and infusion-related reactions, which can indicate allocated arms in clinical trials. Herein, we evaluated the predictive value of AEs using a meta-analysis to estimate their incidence and simulated positive predictive value (PPV). The PPV for ARIA-E was high (0.915), but that for ARIA hemorrhage was low (0.630). Infusion-related reactions had a high PPV of 0.910, but with a wide confidence interval. Our results suggest the need to ameliorate the unblinding effects of AEs, particularly ARIA-E in trials.<\/jats:p>","DOI":"10.3233\/jad-240623","type":"journal-article","created":{"date-parts":[[2024,9,10]],"date-time":"2024-09-10T10:24:39Z","timestamp":1725963879000},"page":"1127-1132","source":"Crossref","is-referenced-by-count":2,"title":["Adverse Events as a Cause of Unblinding of Allocated Arms in Anti-Amyloid Therapy Trials: A Meta-Analysis of the Predictive Value"],"prefix":"10.1177","volume":"101","author":[{"given":"Kenichiro","family":"Sato","sequence":"first","affiliation":[{"name":"Department of Neuropathology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan"},{"name":"Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshiki","family":"Niimi","sequence":"additional","affiliation":[{"name":"Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital, Tokyo, Japan"},{"name":"Department of Healthcare Economics and Health Policy, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryoko","family":"Ihara","sequence":"additional","affiliation":[{"name":"Department of Neurology, Tokyo Metropolitan Institute for Geriatrics and Gerontology, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atsushi","family":"Iwata","sequence":"additional","affiliation":[{"name":"Department of Neurology, Tokyo Metropolitan Institute for Geriatrics and Gerontology, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takeshi","family":"Iwatsubo","sequence":"additional","affiliation":[{"name":"Department of Neuropathology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan"},{"name":"Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","reference":[{"key":"10.3233\/JAD-240623_ref1","first-page":"398","article-title":"Aducanumab: Appropriate use recommendations","volume":"8","author":"Cummings","year":"2021","journal-title":"J Prev Alzheimers Dis"},{"key":"10.3233\/JAD-240623_ref2","first-page":"362","article-title":"Lecanemab: Appropriate use recommendations","volume":"10","author":"Cummings","year":"2023","journal-title":"J Prev Alzheimers Dis"},{"key":"10.3233\/JAD-240623_ref8","doi-asserted-by":"crossref","first-page":"E19","DOI":"10.3174\/ajnr.A7586","article-title":"Amyloid-related imaging abnormalities with emerging Alzheimer disease therapeutics: Detection and reporting recommendations for clinical practice","volume":"43","author":"Cogswell","year":"2022","journal-title":"AJNR Am J Neuroradiol"},{"key":"10.3233\/JAD-240623_ref9","first-page":"211","article-title":"Detection and management of amyloid-related imaging abnormalities in patients with Alzheimer\u2019s disease treated with anti-amyloid beta therapy","volume":"9","author":"Barakos","year":"2022","journal-title":"J Prev Alzheimers Dis"},{"key":"10.3233\/JAD-240623_ref10","doi-asserted-by":"crossref","first-page":"e100","DOI":"10.1093\/brain\/awad171","article-title":"Unblinding in the lecanemab trial in Alzheimer\u2019s disease","volume":"146","author":"Van Gool","year":"2023","journal-title":"Brain"},{"key":"10.3233\/JAD-240623_ref11","doi-asserted-by":"crossref","first-page":"3119","DOI":"10.1002\/alz.13690","article-title":"Potential impact of unblinding on observed treatment effects in Alzheimer\u2019s disease trials","volume":"20","author":"Wolters","year":"2024","journal-title":"Alzheimers Dement"},{"key":"10.3233\/JAD-240623_ref12","doi-asserted-by":"crossref","first-page":"1014","DOI":"10.1097\/j.pain.0000000000000870","article-title":"Side effects can enhance treatment response through expectancy effects: An experimental analgesic randomized 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Ther"},{"key":"10.3233\/JAD-240623_ref16","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1056\/NEJMoa2212948","article-title":"Lecanemab in early Alzheimer\u2019s disease","volume":"388","author":"van Dyck","year":"2023","journal-title":"N Engl J Med"},{"key":"10.3233\/JAD-240623_ref17","doi-asserted-by":"crossref","first-page":"1691","DOI":"10.1056\/NEJMoa2100708","article-title":"Donanemab in early Alzheimer\u2019s disease","volume":"384","author":"Mintun","year":"2021","journal-title":"N Engl J Med"},{"key":"10.3233\/JAD-240623_ref18","doi-asserted-by":"crossref","first-page":"512","DOI":"10.1001\/jama.2023.13239","article-title":"Donanemab in early symptomatic Alzheimer disease: The TRAILBLAZER-ALZ 2 randomized clinical trial","volume":"330","author":"Sims","year":"2023","journal-title":"JAMA"},{"key":"10.3233\/JAD-240623_ref19","doi-asserted-by":"crossref","first-page":"319","DOI":"10.1007\/s00408-021-00458-2","article-title":"Placebo and side effects confound clinical trials on new antitussives","volume":"199","author":"Eccles","year":"2021","journal-title":"Lung"},{"key":"10.3233\/JAD-240623_ref20","unstructured":"Sabbagh M , Cummings JL , van Dyck CH , et al. Isolated ARIA-H in patients treated with lecanemab in the Phase 3 Clarity AD Study in early Alzheimer\u2019s disease. AD\/PD conference. 2024, https:\/\/www.bioarctic.se\/sv\/wpcontent\/uploads\/sites\/4\/2023\/04\/ADPD2023-Isolated-ARIAH.pdf (2023, accessed 5 March 2024)."},{"key":"10.3233\/JAD-240623_ref21","doi-asserted-by":"crossref","first-page":"e12377","DOI":"10.1002\/trc2.12377","article-title":"ARIA in patients treated with lecanemab (BANin a phase 2 study in early Alzheimer\u2019s disease","volume":"9","author":"Honig","year":"2023","journal-title":"Alzheimers Dement (N Y)"}],"container-title":["Journal of Alzheimer's Disease"],"original-title":[],"link":[{"URL":"https:\/\/content.iospress.com\/download?id=10.3233\/JAD-240623","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T09:59:11Z","timestamp":1777370351000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.medra.org\/servlet\/aliasResolver?alias=iospress&doi=10.3233\/JAD-240623"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,8]]},"references-count":16,"journal-issue":{"issue":"4"},"URL":"https:\/\/doi.org\/10.3233\/jad-240623","relation":{},"ISSN":["1387-2877","1875-8908"],"issn-type":[{"value":"1387-2877","type":"print"},{"value":"1875-8908","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10,8]]}}}