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

NEUROBIOLOGY OF AGING

卷:52

Article

Chiotis, Konstantinos¹  Saint-Aubert, Laure¹  Boccardi, Marina^2,3  Gietl, Anton⁴  Picco, Agnese⁵  Varrone, Andrea⁶  Garibotto, Valentina⁷  Herholz, Karl⁸  Nobili, Flavio⁵  Nordberg, Agneta^1,9 

[1] Karolinska Inst, Ctr Alzheimer Res, Dept NVS, Div Translat Alzheimer Neurobiol, Stockholm, Sweden

[2] IRCCS, Cent San Giovanni Dio Fatebenefratelli, Lab Neuroimaging & Alzheimers Epidemiol, Brescia, Italy

[3] Univ Geneva, Dept Psychiat, LANVIE Lab Neuroimaging Aging, Geneva, Switzerland

[4] Univ Zurich, Div Psychiat Res & Psychogeriatr Med, Zurich, Switzerland

[5] Univ Genoa, Dept Neurosci Rehabil Ophthalmol Genet Maternal &, Genoa, Italy

[6] Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Sweden

[7] Univ Hosp Geneva, Dept Neurol, Geneva, Switzerland

[8] Univ Manchester, Wolfson Mol Imaging Ctr, Inst Brain Behav & Mental Hlth, Manchester, Lancs, England

[9] Karolinska Univ Hosp Huddinge, Dept Geriatr Med, Stockholm, Sweden

关键词: Amyloid;    Alzheimer's disease;    Biomarker;    Positron emission tomography;    Development;    Neuroimaging;    Early diagnosis;    Biomarker-based diagnosis;    Clinical validity;    5-Phases;   

DOI  :  10.1016/j.neurobiolaging.2016.07.012

来源: Elsevier

【 摘 要 】

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.

【 授权许可】

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