阿尔茨海默病淀粉样蛋白靶向疾病修饰治疗背景下的体液生物标志物。

IF 12.8 Q1 MEDICINE, RESEARCH & EXPERIMENTAL Med Pub Date : 2024-10-11 Epub Date: 2024-09-09 DOI:10.1016/j.medj.2024.08.004
Yan Hu, Min Cho, Pallavi Sachdev, Jeffrey Dage, Suzanne Hendrix, Oskar Hansson, Randall J Bateman, Harald Hampel
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引用次数: 0

摘要

最近,针对阿尔茨海默病(AD)潜在病理生理学并改变其发展轨迹的单克隆抗体疗法获得批准,阿尔茨海默病(AD)的临床管理和疗法开发进入了一个新时代。成像和体液生物标记物在AD疗法的临床开发中正变得越来越重要。本综述将重点关注近期淀粉样蛋白-β靶向临床试验中的体液生物标志物证据,总结了12项试验的生物标志物数据。它进一步提出了一个简单的框架,将生物标志物指导置于淀粉样蛋白通路靶向疾病修饰的背景下,划分了影响临床试验中生物标志物数据的因素,并强调了知识差距和未来方向。增加有关疾病进展和疾病改变背景下生物标志物的知识和数据将有助于更好地设计未来的AD试验,并指导接受AD改变疗法的患者的临床管理,使我们更接近于在AD中实施精准医疗。
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Fluid biomarkers in the context of amyloid-targeting disease-modifying treatments in Alzheimer's disease.

Clinical management and therapeutics development for Alzheimer's disease (AD) have entered a new era, with recent approvals of monoclonal antibody therapies targeting the underlying pathophysiology of the disease and modifying its trajectory. Imaging and fluid biomarkers are becoming increasingly important in the clinical development of AD therapeutics. This review focuses on the evidence of fluid biomarkers from recent amyloid-β-targeting clinical trials, summarizing biomarker data across 12 trials. It further proposes a simple framework to put biomarker guidance in the context of amyloid-pathway-targeted disease modification, delineates factors that impact biomarker data in clinical trials, and highlights knowledge gaps and future directions. Increased knowledge and data on biomarkers in the context of disease progression and disease modification will help to better design future AD trials and guide the clinical management of patients on AD-modifying therapies, bringing us closer to the implementation of precision medicine in AD.

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来源期刊
Med
Med MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
17.70
自引率
0.60%
发文量
102
期刊介绍: Med is a flagship medical journal published monthly by Cell Press, the global publisher of trusted and authoritative science journals including Cell, Cancer Cell, and Cell Reports Medicine. Our mission is to advance clinical research and practice by providing a communication forum for the publication of clinical trial results, innovative observations from longitudinal cohorts, and pioneering discoveries about disease mechanisms. The journal also encourages thought-leadership discussions among biomedical researchers, physicians, and other health scientists and stakeholders. Our goal is to improve health worldwide sustainably and ethically. Med publishes rigorously vetted original research and cutting-edge review and perspective articles on critical health issues globally and regionally. Our research section covers clinical case reports, first-in-human studies, large-scale clinical trials, population-based studies, as well as translational research work with the potential to change the course of medical research and improve clinical practice.
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