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从 Expedition III 和 EPOCH 试验中我们学到了什么?来自 CTAD 工作组的观点。

What Have We Learned from Expedition III and EPOCH Trials? Perspective of the CTAD Task Force.

机构信息

P.S. Aisen, University of Southern California Alzheimer's Therapeutic Research Institute, San Diego, CA, USA,

出版信息

J Prev Alzheimers Dis. 2018;5(3):171-174. doi: 10.14283/jpad.2018.23.

DOI:10.14283/jpad.2018.23
PMID:29972209
Abstract

Although the results were disappointing from two recent clinical trials of amyloid-targeting drugs in mild-to-moderate AD, the trials provided information that will be important for future studies, according to the EU-US CTAD Task Force, which met in November 2017 to discuss the EXPEDITION3 and EPOCH trials. These trials tested two of the predominant drug development strategies for AD: amyloid immunotherapy and BACE inhibition in populations largely composed of mild AD dementia patients. The results of these trials support the emerging consensus that effective amyloid-targeted treatment will require intervention in early, even pre-symptomatic stages of the disease. Further, the Task Force suggested that a refinement of the amyloid hypothesis may be needed and that other hypotheses should be more fully explored. In addition, they called for improved biomarkers and other outcome assessments to detect the earliest changes in the development of AD.

摘要

尽管最近两项针对轻度至中度 AD 的淀粉样蛋白靶向药物的临床试验结果令人失望,但根据 2017 年 11 月召开的欧盟-美国 CTAD 工作组会议讨论的 EXPEDITION3 和 EPOCH 试验结果,这些试验提供了对未来研究非常重要的信息。这些试验测试了 AD 的两种主要药物开发策略:淀粉样蛋白免疫疗法和 BACE 抑制,试验人群主要由轻度 AD 痴呆患者组成。这些试验结果支持了一种新出现的共识,即有效的淀粉样蛋白靶向治疗将需要在疾病的早期甚至在症状出现前阶段进行干预。此外,工作组还建议可能需要对淀粉样蛋白假说进行修正,并应更充分地探索其他假说。此外,他们呼吁改进生物标志物和其他结果评估方法,以检测 AD 发展过程中的最早变化。

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本文引用的文献

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Delayed-Start Analyses in the Phase 3 Solanezumab EXPEDITION3 Study in Mild Alzheimer's Disease.在轻度阿尔茨海默病的 3 期 Solanezumab EXPEDITION3 研究中进行延迟启动分析。
J Prev Alzheimers Dis. 2018;5(1):8-14. doi: 10.14283/jpad.2018.1.
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Combination Therapy of Anti-Tau and Anti-Amyloid Drugs for Disease Modification in Early-stage Alzheimer's Disease: Socio-economic Considerations Modeled on Treatments for Tuberculosis, HIV/AIDS and Breast Cancer.抗tau蛋白与抗淀粉样蛋白药物联合治疗早期阿尔茨海默病的疾病修饰作用:基于结核病、艾滋病毒/艾滋病和乳腺癌治疗的社会经济考量
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计算机化认知测试在临床试验中的应用:NIH 工具包和 Cogstate C3 电池的比较。
J Prev Alzheimers Dis. 2017;4(1):3-11. doi: 10.14283/jpad.2017.1.
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EU/US/CTAD Task Force: Lessons Learned from Recent and Current Alzheimer's Prevention Trials.欧盟/美国/CTAD 工作组:从最近和当前的阿尔茨海默病预防试验中吸取的经验教训。
J Prev Alzheimers Dis. 2017;4(2):116-124. doi: 10.14283/jpad.2017.13.
5
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