{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T17:27:38Z","timestamp":1777397258224,"version":"3.51.4"},"reference-count":12,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2025,3,20]],"date-time":"2025-03-20T00:00:00Z","timestamp":1742428800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Alzheimer\u2019s Disease"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:p>\n                    Lack of data from the US Food and Drug Administration (FDA) Adverse Event System makes analyses of the risks of newly approved anti-Alzheimer's antibodies inadequate to determine whether such risks justify the minimal clinical benefits reported. A recent disproportionate analysis in the\n                    <jats:italic toggle=\"yes\">Journal of Alzheimer's Disease<\/jats:italic>\n                    by Ge et al. is a case in point. Among serious adverse effects, it only addresses amyloid associated imaging abnormalities, whereas the even more threatening ones, brain tissue loss and therapy-related death, are not mentioned. We urge the FDA to prioritize monitoring of all adverse effects and encourage transparency from the drug manufacturers.\n                  <\/jats:p>","DOI":"10.1177\/13872877251325891","type":"journal-article","created":{"date-parts":[[2025,3,20]],"date-time":"2025-03-20T17:17:51Z","timestamp":1742491071000},"page":"62-64","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["The unsafe profile of lecanemab"],"prefix":"10.1177","volume":"105","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7420-2367","authenticated-orcid":false,"given":"Poul F","family":"H\u00f8ilund-Carlsen","sequence":"first","affiliation":[{"name":"Department of Nuclear Medicine, Odense University Hospital, Odense, Denmark"},{"name":"Department of Clinical Research, University of Southern Denmark, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2373-1781","authenticated-orcid":false,"given":"Thomas J","family":"Werner","sequence":"additional","affiliation":[{"name":"Department of Radiology, University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2442-7901","authenticated-orcid":false,"given":"Abass","family":"Alavi","sequence":"additional","affiliation":[{"name":"Department of Radiology, University of Pennsylvania, Philadelphia, PA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,3,20]]},"reference":[{"key":"e_1_3_4_2_2","article-title":"Unveiling the safety profile of lecanemab: a comprehensive analysis of adverse events using FDA Adverse Event Reporting System Data","author":"Ge W","unstructured":"Ge W, Yan Y, Hu Y, et al. Unveiling the safety profile of lecanemab: a comprehensive analysis of adverse events using FDA Adverse Event Reporting System Data. J Alzheimers Dis. Epub ahead of print 12 January 2025. DOI: 13872877241307246.","journal-title":"J Alzheimers Dis."},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2212948"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.arr.2023.101996"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awac096"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000011832"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.3390\/ijms25073892"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000207156"},{"key":"e_1_3_4_9_2","unstructured":"U.S. Food and Drug Administration. FDA Converts Novel Alzheimer\u2019s Disease Treatment to Traditional Approval https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-converts-novel-alzheimers-disease-treatment-traditional-approval (2023 accessed 18 November 2024)."},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13195-021-00813-8"},{"key":"e_1_3_4_11_2","article-title":"Donanemab: conflicts of interest found in FDA committee that approved new Alzheimer's drug","volume":"386","author":"Lenzer J","year":"2024","unstructured":"Lenzer J, Brownlee S. Donanemab: conflicts of interest found in FDA committee that approved new Alzheimer's drug. BMJ 2024; 386: q2010.","journal-title":"BMJ"},{"key":"e_1_3_4_12_2","unstructured":"Bogdanich W Kessler C. What Drugmakers Did Not Tell Volunteers in Alzheimer\u2019s Trials. The New York Times 23 Oct 2024 https:\/\/www.nytimes.com\/2024\/10\/23\/health\/alzheimers-drug-brain-bleeding.html (2024 accessed 21 November 2024)."},{"key":"e_1_3_4_13_2","unstructured":"European Medicines Agency. Leqembi recommended for treatment of early Alzheimer\u2019s disease. https:\/\/www.ema.europa.eu\/en\/news\/leqembi-recommended-treatment-early-alzheimers-disease (2024 accessed 18 January 2025)."}],"container-title":["Journal of Alzheimer\u2019s Disease"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13872877251325891","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/13872877251325891","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/13872877251325891","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T10:10:10Z","timestamp":1777371010000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/13872877251325891"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,20]]},"references-count":12,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,5]]}},"alternative-id":["10.1177\/13872877251325891"],"URL":"https:\/\/doi.org\/10.1177\/13872877251325891","relation":{},"ISSN":["1387-2877","1875-8908"],"issn-type":[{"value":"1387-2877","type":"print"},{"value":"1875-8908","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,20]]}}}