欧洲阿尔茨海默病联盟（EADC）研究人员对人用药品委员会（CHMP）关于多奈单抗用于早期阿尔茨海默病上市许可的否定性建议的评论。 - Suppr

Comment by European Alzheimer's Disease Consortium (EADC) investigators on the negative recommendation of the CHMP on the marketing authorization of donanemab for early Alzheimer' s disease.

作者信息

Jessen Frank, Arbizu Javier, Boada Mercé, Balasa Mircea, Bennys Karim, Boban Marina, Bürger Katharina, Chincarini Andrea, Cagnin Annachiara, De Deyn Peter Paul, Düzel Emrah, Engelborghs Sebastiaan, Ewers Michael, Exalto Lieza G, van der Flier Wiesje M, Fortea Juan, Frederiksen Kristian Steen, Frisoni Giovanni B, Frölich Lutz, Garza-Martinez Alejandro J, Grimmer Timo, Hanseeuw Bernard, Hort Jakub, Ivanoiu Adrian, Kehoe Patrick G, Kennelly Sean P, Kern Silke, Klöppel Stefan, Krajčovičová Lenka, Kramberger Milica G, McGuinness Bernadette, Mecocci Patrizia, Oberstein Timo Jan, Ousset Pierre-Jean, Paquet Claire, Perneczky Robert, Piazza Fabrizio, Plantone Domenico, Rainero Innocenzo, Sacco Guillaume, Salmon Eric, Santana Isabel, Scarmeas Nikolaos, Schneider Anja, Schott Jonathan M, Solje Eino, Stefanova Elka, Stögmann Elisabeth, Strauss Mélanie, Sutovsky Stanislav, Waldemar Gunhild, Winblad Bengt

机构信息

Department of Psychiatry, University of Cologne, Medical Faculty, Cologne, Germany; German Center for Neurodegenerative Diseases (DZNE), Bonn/Cologne, Germany.

Department of Nuclear Medicine, University of Navarre Clinic, Pamplona-Madrid, Spain; Navarra Institute for Health Research (IdiSNA), Pamplona, Spain.

出版信息

J Prev Alzheimers Dis. 2025 Sep;12(8):100259. doi: 10.1016/j.tjpad.2025.100259. Epub 2025 Jul 9.

DOI:10.1016/j.tjpad.2025.100259

PMID:40640062

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12413728/

Abstract

摘要

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本文引用的文献

Modified titration of donanemab reduces ARIA risk and maintains amyloid reduction.多奈单抗的改良滴定法可降低淀粉样蛋白相关影像异常（ARIA）风险并维持淀粉样蛋白减少效果。

Alzheimers Dement. 2025 Apr;21(4):e70062. doi: 10.1002/alz.70062.

JAMA Neurol. 2025 May 1;82(5):461-469. doi: 10.1001/jamaneurol.2025.0065.

Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial.多奈哌齐治疗早期症状性阿尔茨海默病的随机临床试验。

JAMA. 2023 Aug 8;330(6):512-527. doi: 10.1001/jama.2023.13239.

Lecanemab in Early Alzheimer's Disease.早期阿尔茨海默病中的lecanemab

N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29.

Donanemab in Early Alzheimer's Disease.多奈单抗用于早期阿尔茨海默病

N Engl J Med. 2021 May 6;384(18):1691-1704. doi: 10.1056/NEJMoa2100708. Epub 2021 Mar 13.

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