The National Institute on Aging-Alzheimer's Association Framework on Alzheimer's disease: Application to clinical trials.

The National Institute on Aging-Alzheimer's Association Framework on Alzheimer's disease: Application to clinical trials.
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DOI:
10.1016/j.jalz.2018.05.006
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发表时间:
2019-01
期刊:
Alzheimer's & dementia : the journal of the Alzheimer's Association
影响因子:
--
通讯作者:
Cummings J
Cummings J
中科院分区:
其他
文献类型:
--
作者:
Cummings J

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NIA-AA阿尔茨海默病研究框架代表了阿尔茨海默病(AD)谱生物学特征的重要进展。NIA-AA框架被认为适用于临床试验。使用淀粉样蛋白(A),tau(T)和神经变性(N)生物标志物的组合,该框架提供了一种定义阿尔茨海默病病理变化患者状态的方法。该框架与疾病缓解剂的临床试验相关,允许参与者在基线时进行生物学表征。ATN框架还可以为试验结果提供信息。淀粉样蛋白沉积后疾病的临床前阶段定义为A+T-N-,转变为前驱疾病和痴呆的特征是T和N的增加。临床试验中大多数有症状的患者属于A+T+N-和A+T+N+类别。NIA-AA阿尔茨海默病框架代表了在提供AD谱参与者的生物标志物概况方面的进展,可用于帮助设计临床试验。
The NIA-AA Research Framework on Alzheimer’s Disease represents an important advance in the biological characterization of the Alzheimer’s disease (AD) spectrum. The NIA-AA Framework is considered as it applies to clinical trials. Using the combination of amyloid (A), tau (T), and neurodegeneration (N) biomarkers, the Framework provides a means of defining the state of patients with regard to Alzheimer pathologic change. The Framework is relevant to clinical trials of disease-modifying agents allowing participants to be characterized biologically at baseline. The ATN Framework can also inform trial outcomes. The preclinical phase of the disease after amyloid deposition is defined by A+T-N- and the transition to prodromal disease and dementia is characterized by the addition of T and N. Most symptomatic patients in clinical trials are in the class of A+T+N- and A+T+N+. The NIA-AA Framework on Alzheimer’s Disease represents progress in providing biomarker profiles of participants in the AD spectrum that can be used to help design clinical trials.
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