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1
The science does not yet support regulatory approval of amyloid-targeting therapies for Alzheimer's disease based solely on biomarker evidence.目前，仅基于生物标志物证据，科学上尚不支持对阿尔茨海默病的淀粉样蛋白靶向疗法进行监管批准。
Alzheimers Dement. 2025 Apr;21(4):e70068. doi: 10.1002/alz.70068.
2
The case for regulatory approval of amyloid-lowering immunotherapies in Alzheimer's disease based on clearcut biomarker evidence.基于明确的生物标志物证据，批准用于阿尔茨海默病的降低淀粉样蛋白免疫疗法的理由。
Alzheimers Dement. 2025 Jan;21(1):e14342. doi: 10.1002/alz.14342. Epub 2024 Nov 13.
3
Considerations for biomarker strategies in clinical trials investigating tau-targeting therapeutics for Alzheimer's disease.探讨针对阿尔茨海默病的tau 靶向治疗药物的临床试验中生物标志物策略的考虑因素。
Transl Neurodegener. 2024 May 21;13(1):25. doi: 10.1186/s40035-024-00417-w.
4
Benefits and risks of FDA-approved amyloid-targeting antibodies for treatment of early Alzheimer's disease: Navigating clinician-patient engagement.FDA 批准的用于治疗早期阿尔茨海默病的淀粉样蛋白靶向抗体的获益和风险：临床医生与患者的互动。
Alzheimers Dement. 2024 Nov;20(11):8162-8171. doi: 10.1002/alz.14199. Epub 2024 Sep 22.
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High-clearance anti-amyloid immunotherapies in Alzheimer's disease. Part 2: putative scenarios and timeline in case of approval, recommendations for use, implementation, and ethical considerations in France.阿尔茨海默病中的高清除率抗淀粉样蛋白免疫疗法。第2部分：获批后的假定情况和时间线、法国的使用建议、实施及伦理考量
Rev Neurol (Paris). 2022 Dec;178(10):999-1010. doi: 10.1016/j.neurol.2022.08.002. Epub 2022 Nov 3.
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Alzheimer's disease drug development in an evolving therapeutic landscape.不断演变的治疗格局下的阿尔茨海默病药物研发
Alzheimers Dement (N Y). 2024 Nov 30;10(4):e70015. doi: 10.1002/trc2.70015. eCollection 2024 Oct-Dec.
7
Alzheimer's Disease is Driven by Intraneuronally Retained Beta-Amyloid Produced in the AD-Specific, βAPP-Independent Pathway: Current Perspective and Experimental Models for Tomorrow.阿尔茨海默病由在AD特异性、β-淀粉样前体蛋白（βAPP）非依赖途径中产生并在神经元内保留的β-淀粉样蛋白驱动：当前观点及未来实验模型
Ann Integr Mol Med. 2020;2(1):90-114. doi: 10.33597/aimm.02-1007.
8
Impacts of FDA approval and Medicare restriction on antiamyloid therapies for Alzheimer's disease: patient outcomes, healthcare costs, and drug development.美国食品药品监督管理局（FDA）批准及医疗保险限制对阿尔茨海默病抗淀粉样蛋白疗法的影响：患者预后、医疗成本及药物研发
Lancet Reg Health Am. 2023 Mar 1;20:100467. doi: 10.1016/j.lana.2023.100467. eCollection 2023 Apr.
9
Aducanumab, gantenerumab, BAN2401, and ALZ-801-the first wave of amyloid-targeting drugs for Alzheimer's disease with potential for near term approval.阿杜卡奴单抗、根特纳单抗、BAN2401 和 ALZ-801——用于治疗阿尔茨海默病的首批靶向淀粉样蛋白药物，具有近期获批的潜力。
Alzheimers Res Ther. 2020 Aug 12;12(1):95. doi: 10.1186/s13195-020-00663-w.
10
Anti-Amyloid Therapies for Alzheimer's Disease: An Alzheimer Europe Position Paper and Call to Action.抗淀粉样蛋白疗法治疗阿尔茨海默病：阿尔茨海默病欧洲立场文件和行动呼吁。
J Prev Alzheimers Dis. 2024;11(2):265-273. doi: 10.14283/jpad.2024.37.

引用本文的文献

1
Evaluation of Amyloid Removal as a Surrogate for Cognitive Decline: Pilot Analysis in Individual-Level Data from the A4 Study of Solanezumab.评估淀粉样蛋白清除作为认知衰退替代指标的研究：来自索拉珠单抗A4研究个体水平数据的初步分析
medRxiv. 2025 Jul 22:2025.07.21.25331942. doi: 10.1101/2025.07.21.25331942.
2
Reconsidering dopaminergic modulation in Alzheimer's disease: A case for levodopa/carbidopa as a disease-modifying agent.重新审视阿尔茨海默病中的多巴胺能调节：左旋多巴/卡比多巴作为疾病修饰剂的案例。
Alzheimers Dement. 2025 Jul;21(7):e70532. doi: 10.1002/alz.70532.

本文引用的文献

1
The case for regulatory approval of amyloid-lowering immunotherapies in Alzheimer's disease based on clearcut biomarker evidence.基于明确的生物标志物证据，批准用于阿尔茨海默病的降低淀粉样蛋白免疫疗法的理由。
Alzheimers Dement. 2025 Jan;21(1):e14342. doi: 10.1002/alz.14342. Epub 2024 Nov 13.
2
Alzheimer Disease as a Clinical-Biological Construct-An International Working Group Recommendation.作为一种临床生物学概念的阿尔茨海默病——国际工作组建议
JAMA Neurol. 2024 Dec 1;81(12):1304-1311. doi: 10.1001/jamaneurol.2024.3770.
3
Disentangling clinical and biological trajectories of neurodegenerative diseases.厘清神经退行性疾病的临床和生物学轨迹。
Nat Rev Neurol. 2024 Dec;20(12):693-694. doi: 10.1038/s41582-024-01004-3.
4
Gantenerumab in Early Alzheimer's Disease. Reply.
N Engl J Med. 2024 Feb 29;390(9):867. doi: 10.1056/NEJMc2314291.
5
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.
6
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.
7
Two Randomized Phase 3 Studies of Aducanumab in Early Alzheimer's Disease.两项早期阿尔茨海默病中阿杜卡努单抗的随机 3 期研究。
J Prev Alzheimers Dis. 2022;9(2):197-210. doi: 10.14283/jpad.2022.30.
8
US Food and Drug Administration Approval of Aducanumab-Is Amyloid Load a Valid Surrogate End Point for Alzheimer Disease Clinical Trials?美国食品药品监督管理局对阿杜卡努单抗的批准——淀粉样蛋白负荷是阿尔茨海默病临床试验的有效替代终点吗？
JAMA Neurol. 2021 Nov 1;78(11):1307-1308. doi: 10.1001/jamaneurol.2021.3126.
9
Are surrogate markers adequate to assess cardiovascular disease drugs?替代标志物是否足以评估心血管疾病药物？
JAMA. 1999 Aug 25;282(8):790-5. doi: 10.1001/jama.282.8.790.
10
Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial.接受恩卡尼、氟卡尼或安慰剂治疗患者的死亡率和发病率。心律失常抑制试验。
N Engl J Med. 1991 Mar 21;324(12):781-8. doi: 10.1056/NEJM199103213241201.

The science does not yet support regulatory approval of amyloid-targeting therapies for Alzheimer's disease based solely on biomarker evidence.

作者信息

Planche Vincent, Schindler Suzanne, Knopman David S, Frisoni Giovanni, Galasko Douglas, Grill Joshua D, Schneider Lon, Karlawish Jason, Villain Nicolas

机构信息

Univ. Bordeaux, CNRS, Institut des Maladies Neurodégénératives, Bordeaux, France.

Pôle de Neurosciences Cliniques, Centre Mémoire de Ressources et de Recherche, CHU de Bordeaux, Bordeaux, France.

出版信息

Alzheimers Dement. 2025 Apr;21(4):e70068. doi: 10.1002/alz.70068.

DOI:10.1002/alz.70068
PMID:40243238
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12004391/
Abstract
摘要