Research and standardization in Alzheimer's trials: Reaching international consensus

Research and standardization in Alzheimer's trials: Reaching international consensus
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DOI:
10.1016/j.jalz.2012.10.006
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发表时间:
2013-03-01
影响因子:
14
通讯作者:
Head, Richard J.
Head, Richard J.
中科院分区:
医学1区
文献类型:
--
作者:
Carrillo, Maria C.;Rowe, Christopher C.;Head, Richard J.

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阿尔茨海默病(AD)是一种世界性流行病。在过去25年中获得的越来越多的知识表明,AD沿着临床和神经病理频谱发展,表现为从没有症状的临床前疾病到早期症状阶段,最后到AD痴呆。阿尔茨海默氏症研究界认识到,成像、体液和认知生物标记物有助于增强AD的诊断信心。在临床试验中使用AD生物标记物也出现了新的共识。由于缺乏标准化,生物标记物在临床试验和实践中的使用受到阻碍。为了应对新出现的标准化需求,2012年3月在澳大利亚墨尔本召开了AD研究人员国际会议,将主要研究人员、临床医生、行业和监管利益相关者聚集在一起,目的是就认知、成像和流体生物标记物以及全球研究中心使用的生活方式参数的标准化和验证达成共识。(C)2013年阿尔茨海默氏症协会。版权所有。
Alzheimer's disease (AD) is an epidemic facing the entire world. Increased knowledge gained during the past 25 years indicates that AD falls along a clinical and neuropathological spectrum represented as a continuum that extends from preclinical disease in which there are no symptoms, through early symptomatic phases, and finally to AD dementia. The Alzheimer's research community recognizes that imaging, body fluids, and cognitive biomarkers contribute to enhanced diagnostic confidence for AD. There has also been emerging consensus regarding the use of AD biomarkers in clinical trials. The use of biomarkers in clinical trials and practice is hampered by the lack of standardization. In response to the emerging need for standardization, an international meeting of AD researchers was held in Melbourne, Australia, in March 2012 to bring together key researchers, clinicians, industry, and regulatory stakeholders with the aim of generating consensus on standardization and validation of cognitive, imaging, and fluid biomarkers, as well as lifestyle parameters used in research centers worldwide. (c) 2013 The Alzheimer's Association. All rights reserved.