Alzheimer's prevention initiative: a proposal to evaluate presymptomatic treatments as quickly as possible.
Alzheimer's prevention initiative: a proposal to evaluate presymptomatic treatments as quickly as possible.
复制标题
DOI：
10.2217/bmm.09.91
复制
发表时间：
2010-02
影响因子：
2.2
通讯作者：
Tariot PN
中科院分区：
文献类型：
--
作者：
Reiman EM;Langbaum JB;Tariot PN
现在是时候启动阿尔茨海默病（AD）预防研究的时代，建立快速评估症状前AD治疗的方法和基础设施，并在随机临床试验中对其进行严格和快速的评估。这篇文章是一个战斗的号召。它认为，对症状前AD治疗的评估必须成为一个紧迫的优先事项，它确定了阻碍我们前进的因素，并提出了新的公共政策和科学策略来克服这些障碍。它定义了术语“症状前AD治疗”，指出了AD进展和病理学的最佳生物标志物，并建议如何使用它们来快速评估有风险人群的症状前AD治疗。它介绍了一种方法来评估症状前AD治疗的无症状的人在最高的风险即将临床发作，并确定治疗的生物标志物预测临床结果的程度。我们提出了一项阿尔茨海默氏症预防倡议，目前正在与领先的学术和行业调查人员合作进行审查和完善。它旨在评估最有前途的症状前AD治疗，帮助开发一种监管途径，以使用合理可能的替代终点加速批准，并尽快找到可证明有效的症状前AD治疗。
Now is the time to launch the era of Alzheimer’s disease (AD) prevention research, establish the methods and infrastructure to rapidly evaluate presymptomatic AD treatments and evaluate them rigorously and rapidly in randomized clinical trials. This article is a call to arms. It contends that the evaluation of presymptomatic AD treatments must become an urgent priority, it identifies what is holding us back and proposes new public policies and scientific strategies to overcome these roadblocks. It defines the term ‘presymptomatic AD treatment,’ notes the best established biomarkers of AD progression and pathology and suggests how they could be used to rapidly evaluate presymptomatic AD treatments in the people at risk. It introduces an approach to evaluate presymptomatic AD treatments in asymptomatic people at the highest risk of imminent clinical onset and determines the extent to which the treatment’s biomarker predicts a clinical outcome. We propose an Alzheimer’s Prevention Initiative, which is now being reviewed and refined in partnership with leading academic and industry investigators. It is intended to evaluate the most promising presymptomatic AD treatments, help develop a regulatory pathway for their accelerated approval using reasonably likely surrogate end points and find demonstrably effective presymptomatic AD treatments as quickly as possible.