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Are lecanemab and donanemab disease-modifying therapies?

作者信息

Daly Timothy, Kepp Kasper P, Imbimbo Bruno P

机构信息

Bioethics Program, FLACSO Argentina, Tucumán, Buenos Aires, Argentina.

Science Norms Democracy, UMR 8011 Sorbonne University, Paris, France.

出版信息

Alzheimers Dement. 2024 Sep;20(9):6659-6661. doi: 10.1002/alz.14114. Epub 2024 Aug 3.

DOI:10.1002/alz.14114
PMID:39096161
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11497653/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b64e/11497653/9c428b5ac193/ALZ-20-6659-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b64e/11497653/9c428b5ac193/ALZ-20-6659-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b64e/11497653/9c428b5ac193/ALZ-20-6659-g001.jpg

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本文引用的文献

1
Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments.替代标志物与非肿瘤慢性疾病治疗的临床结局之间的关联。
JAMA. 2024 May 21;331(19):1646-1654. doi: 10.1001/jama.2024.4175.
2
Biomarker-based staging of Alzheimer disease: rationale and clinical applications.基于生物标志物的阿尔茨海默病分期：原理与临床应用。
Nat Rev Neurol. 2024 Apr;20(4):232-244. doi: 10.1038/s41582-024-00942-2. Epub 2024 Mar 1.
3
Potential impact of unblinding on observed treatment effects in Alzheimer's disease trials.
Alzheimers Dement. 2025 Feb;21(2):e14520. doi: 10.1002/alz.14520. Epub 2025 Jan 8.
4
Strategies of positron emission tomography (PET) tracer development for imaging of tau and α-synuclein in neurodegenerative disorders.用于神经退行性疾病中tau蛋白和α-突触核蛋白成像的正电子发射断层扫描（PET）示踪剂开发策略。
RSC Med Chem. 2024 Nov 20. doi: 10.1039/d4md00576g.
阿尔茨海默病临床试验中揭盲对观察到的治疗效果的潜在影响。
Alzheimers Dement. 2024 Apr;20(4):3119-3125. doi: 10.1002/alz.13690. Epub 2024 Feb 21.
4
Comparison of relative change with effect size metrics in Alzheimer's disease clinical trials.阿尔茨海默病临床试验中相对变化与效应大小指标的比较。
J Neurol Neurosurg Psychiatry. 2023 Dec 14;95(1):2-7. doi: 10.1136/jnnp-2023-331941.
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Evaluation of clinical benefits of treatments for Alzheimer's disease.评估阿尔茨海默病治疗的临床获益。
Lancet Healthy Longev. 2023 Nov;4(11):e645-e651. doi: 10.1016/S2666-7568(23)00193-9.
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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.
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Advocating for Demonstration of Disease Modification-Have We Been Approaching Clinical Trials in Early Alzheimer Disease Incorrectly?倡导疾病修饰的论证——我们对早期阿尔茨海默病临床试验的方法是否有误？
JAMA Neurol. 2023 Jul 1;80(7):659-660. doi: 10.1001/jamaneurol.2023.0815.
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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.
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Testing the amyloid cascade hypothesis: Prevention trials in autosomal dominant Alzheimer disease.测试淀粉样蛋白级联假说：常染色体显性阿尔茨海默病的预防试验。
Alzheimers Dement. 2022 Dec;18(12):2687-2698. doi: 10.1002/alz.12624. Epub 2022 Feb 24.
10
The amyloid hypothesis in Alzheimer disease: new insights from new therapeutics.阿尔茨海默病中的淀粉样蛋白假说：新疗法的新见解。
Nat Rev Drug Discov. 2022 Apr;21(4):306-318. doi: 10.1038/s41573-022-00391-w. Epub 2022 Feb 17.