Clinical validity of increased cortical uptake of amyloid ligands on PET as a biomarker for Alzheimer's disease in the context of a structured 5-phase development framework
Clinical validity of increased cortical uptake of amyloid ligands on PET as a biomarker for Alzheimer's disease in the context of a structured 5-phase development framework
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DOI：
10.1016/j.neurobiolaging.2016.07.012
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发表时间：
2017-04-01
影响因子：
4.2
通讯作者：
Nordberg, Agneta
中科院分区：
文献类型：
--
作者：
Chiotis, Konstantinos;Saint-Aubert, Laure;Nordberg, Agneta
在最近的标准中，已经提出使用生物标志物来诊断阿尔茨海默病，但一些生物标志物尚未得到充分的研究，以证明其常规临床应用的合理性。在这里，我们在一篇文献综述中评估了淀粉样蛋白正电子发射断层扫描（PET）成像的临床有效性，该成像使用了用于评估肿瘤生物标志物的结构化框架。同质标准已经在其他阿尔茨海默病生物标志物的综述中得到解决。有充分的证据表明，第1阶段（使用的理由）和第2阶段（辨别能力）的主要目标已经实现。3期目标（早期发现能力）已经部分实现，而4期研究（在代表性轻度认知障碍患者中的表现）目前正在进行中。第五阶段的研究（量化影响和成本）仍在进行中。这篇综述强调了在临床环境中正确使用淀粉样蛋白PET成像的优先事项。未来的研究将主要是大型的4期研究，以评估淀粉样蛋白PET成像在常规临床实践中的应用。(C) 2016 Elsevier Inc.版权所有。
The use of biomarkers has been proposed for diagnosing Alzheimer's disease in recent criteria, but some biomarkers have not been sufficiently investigated to justify their routine clinical use. Here, we evaluate in a literature review the clinical validity of amyloid positron emission tomography (PET) imaging using a structured framework developed for the assessment of oncological biomarkers. Homogenous criteria have been addressed in reviews of other Alzheimer's disease biomarkers. There is adequate evidence that the main aims of phases 1 (rationale for use) and 2 (discriminative ability) have been achieved. The aims of phase 3 (early detection ability) have been partly achieved, while phase 4 studies (performance in representative mild cognitive impairment patients) are currently ongoing. Phase 5 studies (quantification of impact and costs) are still to come. This review highlights the priorities to be pursued to enable the proper use of amyloid PET imaging in a clinical setting. Future investigations will primarily be large, phase 4 studies that will assess the utility of amyloid PET imaging in routine clinical practice. (C) 2016 Elsevier Inc. All rights reserved.