临床试验
医学
疾病
替代医学
框架(结构)
临床终点
临床疾病
重症监护医学
梅德林
临床研究设计
终点测定
研究设计
心理学
作者
Pierre N. Tariot,Samuel P. Dickson,John R. Dwyer,Carlos Granda,Lynne Hughes,Jason H. Karlawish,Nicklas Linz,Kavita V. Nair,Russ Paulsen,Daniel Pawson,Robert Perneczky,Suzanne E. Schindler,Emily Scholler,James Taylor,Ben Tiede,George Vradenburg
摘要
Disease-targeted therapies (DTTs) for Alzheimer's disease (AD) represent a major advance, yet challenges remain on how best to interpret and communicate their benefits. As clinical development increasingly targets the earliest stages of AD (before symptoms emerge and early symptomatic AD), there is a need for novel, complementary endpoints and improved communication of treatment benefits. The Global CEO Initiative on Alzheimer's Disease convened a multi-stakeholder working group to develop recommendations for improving the design and communication of endpoints in AD clinical trials. In the near term, communication can be improved by contextualizing treatment effects at the individual level, including framing benefits in terms of responder analyses and "time saved" over defined timeframes. In parallel, continued development of complementary endpoints is needed to enable more sensitive, scalable, and patient-centered measurements aligned with early intervention. These recommendations aim to support stakeholders in evaluating and communicating the meaningful benefits of current and emerging therapies.
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