Chiotis Konstantinos, Saint-Aubert Laure, Boccardi Marina, Gietl Anton, Picco Agnese, Varrone Andrea, Garibotto Valentina, Herholz Karl, Nobili Flavio, Nordberg Agneta
Center for Alzheimer Research, Division of Translational Alzheimer Neurobiology, Department of NVS, Karolinska Institutet, Stockholm, Sweden.
Laboratory of Neuroimaging and Alzheimer's Epidemiology, IRCCS Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy; LANVIE (Laboratory of Neuroimaging of Aging) - Department of Psychiatry, University of Geneva, Geneva, Switzerland.
Neurobiol Aging. 2017 Apr;52:214-227. doi: 10.1016/j.neurobiolaging.2016.07.012.
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.
在最近的诊断标准中，有人提议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研究，无法证明其在临床常规使用中的合理性。在此，我们通过文献综述，使用为评估肿瘤生物标志物而开发的结构化框架，来评估淀粉样蛋白正电子发射断层扫描（PET）成像的临床有效性。其他阿尔茨海默病生物标志物的综述中已经涉及了统一标准。有充分证据表明，第1阶段（使用理由）和第2阶段（鉴别能力）的主要目标已经实现。第3阶段（早期检测能力）的目标已部分实现，而第4阶段研究（在有代表性的轻度认知障碍患者中的表现）目前正在进行。第5阶段研究（影响和成本的量化）尚待开展。本综述强调了在临床环境中正确使用淀粉样蛋白PET成像应优先考虑的事项。未来的研究将主要是大型的第4阶段研究，这些研究将评估淀粉样蛋白PET成像在常规临床实践中的效用。
