Talking points for physicians, patients and caregivers considering Aduhelm® infusion and the accelerated pathway for its approval by the FDA.
作者信息
Gandy Sam, Knopman David S, Sano Mary
机构信息
Department of Psychiatry, NIA-Designated Mount Sinai Alzheimer's Disease Research Center, New York, NY, 10029, USA.
James J Peters VA Medical Center, Bronx, NY, 10468, USA.
出版信息
Mol Neurodegener. 2021 Nov 4;16(1):74. doi: 10.1186/s13024-021-00490-z.
Abstract
摘要
相似文献
1
Talking points for physicians, patients and caregivers considering Aduhelm® infusion and the accelerated pathway for its approval by the FDA.供考虑使用阿杜海姆（Aduhelm®）输液疗法及其通过美国食品药品监督管理局（FDA）加速审批途径的医生、患者及护理人员的谈话要点。
Mol Neurodegener. 2021 Nov 4;16(1):74. doi: 10.1186/s13024-021-00490-z.
2
Aducanumab produced a clinically meaningful benefit in association with amyloid lowering.阿杜卡努单抗在降低淀粉样蛋白的同时产生了具有临床意义的益处。
Alzheimers Res Ther. 2021 May 10;13(1):98. doi: 10.1186/s13195-021-00838-z.
3
What's in It for Me? Contextualizing the Potential Clinical Impacts of Lecanemab, Donanemab, and Other Anti-β-amyloid Monoclonal Antibodies in Early Alzheimer's Disease.对我有什么好处？在早期阿尔茨海默病中，情境化评估 LeCanemab、Donanemab 和其他抗β-淀粉样蛋白单克隆抗体的潜在临床影响。
eNeuro. 2024 Sep 27;11(9). doi: 10.1523/ENEURO.0088-24.2024. Print 2024 Sep.
4
Aducanumab-Related Amyloid-Related Imaging Abnormalities: Paean or Lament?阿杜卡奴单抗相关淀粉样蛋白相关影像学异常：赞歌还是悲歌？
Clin Nucl Med. 2022 Jul 1;47(7):625-626. doi: 10.1097/RLU.0000000000004250. Epub 2022 Apr 22.
5
Lecanemab, Aducanumab, and Gantenerumab - Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer's Disease.仑卡奈单抗、阿杜卡玛单抗和加内替单抗——对不同形式的淀粉样蛋白-β的结合谱可能解释了阿尔茨海默病临床试验中的疗效和副作用。
Neurotherapeutics. 2023 Jan;20(1):195-206. doi: 10.1007/s13311-022-01308-6. Epub 2022 Oct 17.
6
How promising are the latest monoclonal antibodies targeting amyloid-β for the treatment of early Alzheimer's disease?针对淀粉样蛋白-β的最新单克隆抗体治疗早期阿尔茨海默病的前景如何？
Expert Opin Emerg Drugs. 2024 Mar;29(1):35-43. doi: 10.1080/14728214.2024.2304059. Epub 2024 Jan 12.
7
Aducanumab for Alzheimer's disease: A regulatory perspective.阿杜卡奴单抗治疗阿尔茨海默病：监管视角。
Pharmacol Res. 2021 Sep;171:105754. doi: 10.1016/j.phrs.2021.105754. Epub 2021 Jul 2.
8
Aducanumab (Marketed as Aduhelm) Approval Is Likely Based on Misinterpretation of PET Imaging Data.阿杜卡奴单抗（商品名为 Aduhelm）的获批可能基于对 PET 成像数据的误解。
J Alzheimers Dis. 2021;84(4):1457-1460. doi: 10.3233/JAD-215275.
9
Profiling lecanemab as a treatment option for Alzheimer's disease.剖析 Lecanemab 作为阿尔茨海默病的治疗选择。
Expert Rev Neurother. 2024 May;24(5):433-441. doi: 10.1080/14737175.2024.2333970. Epub 2024 Apr 3.
10
What to Know About the Alzheimer Drug Aducanumab (Aduhelm).关于阿尔茨海默病药物阿杜卡努单抗（Aduhelm）需要了解的事项。
JAMA Intern Med. 2022 Aug 1;182(8):892. doi: 10.1001/jamainternmed.2022.1039.
引用本文的文献
1
Familiarity and Perceptions of Aducanumab in Caregivers of Hawaii Alzheimer's Disease Patients: Results of a Telephone Survey.夏威夷阿尔茨海默病患者照料者对阿杜卡努单抗的熟悉程度与认知：电话调查结果
Cureus. 2023 Dec 5;15(12):e50001. doi: 10.7759/cureus.50001. eCollection 2023 Dec.
2
Open peer commentary on "Prescribing anti-amyloid immunotherapies to treat Alzheimer's disease: Fully informing patient decisions".关于“开具抗淀粉样蛋白免疫疗法治疗阿尔茨海默病：充分告知患者决策”的公开同行评论
Alzheimers Dement (N Y). 2023 Nov 20;9(4):e12437. doi: 10.1002/trc2.12437. eCollection 2023 Oct-Dec.
3
News & views: anti-amyloid antibodies and novel emerging approaches to Alzheimer's disease in 2023.新闻与观点：2023年抗淀粉样蛋白抗体及阿尔茨海默病的新兴治疗方法
Mol Neurodegener. 2023 Sep 25;18(1):66. doi: 10.1186/s13024-023-00656-x.
4
Dual-Specificity Protein Phosphatase 4 (DUSP4) Overexpression Improves Learning Behavior Selectively in Female 5xFAD Mice, and Reduces β-Amyloid Load in Males and Females.双特异性蛋白磷酸酶 4（DUSP4）过表达选择性改善 5xFAD 雌性小鼠的学习行为，并降低雌雄两性的β-淀粉样蛋白负荷。
Cells. 2022 Dec 1;11(23):3880. doi: 10.3390/cells11233880.
5
ApoE in Alzheimer's disease: pathophysiology and therapeutic strategies.载脂蛋白 E 在阿尔茨海默病中的作用：发病机制与治疗策略。
Mol Neurodegener. 2022 Nov 8;17(1):72. doi: 10.1186/s13024-022-00574-4.
6
ApoE4 reduction: An emerging and promising therapeutic strategy for Alzheimer's disease.载脂蛋白 E4 减少：阿尔茨海默病的一种新兴且有前途的治疗策略。
Neurobiol Aging. 2022 Jul;115:20-28. doi: 10.1016/j.neurobiolaging.2022.03.011. Epub 2022 Mar 22.
7
Alzheimer's disease - the journey of a healthy brain into organ failure.阿尔茨海默病——一个健康大脑走向器官衰竭的旅程。
Mol Neurodegener. 2022 Mar 5;17(1):18. doi: 10.1186/s13024-022-00523-1.
本文引用的文献
1
Aducanumab: Appropriate Use Recommendations.阿杜卡奴单抗：合理使用建议。
J Prev Alzheimers Dis. 2021;8(4):398-410. doi: 10.14283/jpad.2021.41.
2
The need to show minimum clinically important differences in Alzheimer's disease trials.在阿尔茨海默病临床试验中需要显示最小临床重要差异。
Lancet Psychiatry. 2021 Nov;8(11):1013-1016. doi: 10.1016/S2215-0366(21)00197-8. Epub 2021 Jun 1.
3
A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβ protofibril antibody.一项针对早期阿尔茨海默病的仑卡奈单抗（抗 Aβ 原纤维抗体）的随机、双盲、2b 期概念验证临床试验。
Alzheimers Res Ther. 2021 Apr 17;13(1):80. doi: 10.1186/s13195-021-00813-8.
4
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.
5
The National Institute on Aging and the Alzheimer's Association Research Framework for Alzheimer's disease: Perspectives from the Research Roundtable.美国国家老龄化研究所和阿尔茨海默病协会阿尔茨海默病研究框架：研究圆桌会议的观点。
Alzheimers Dement. 2018 Apr;14(4):563-575. doi: 10.1016/j.jalz.2018.03.002.
6
NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease.NIA-AA 研究框架：迈向阿尔茨海默病的生物学定义。
Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
7
The antibody aducanumab reduces Aβ plaques in Alzheimer's disease.阿杜卡努单抗可减少阿尔茨海默病中的 Aβ 斑块。
Nature. 2016 Sep 1;537(7618):50-6. doi: 10.1038/nature19323.
8
11C-PiB PET assessment of change in fibrillar amyloid-beta load in patients with Alzheimer's disease treated with bapineuzumab: a phase 2, double-blind, placebo-controlled, ascending-dose study.11C-PiB PET 评估 bapineuzumab 治疗阿尔茨海默病患者纤维状淀粉样β负荷的变化：一项 2 期、双盲、安慰剂对照、递增剂量研究。
Lancet Neurol. 2010 Apr;9(4):363-72. doi: 10.1016/S1474-4422(10)70043-0. Epub 2010 Feb 26.
Zotero 插件