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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


Chiotis, Konstantinos; Saint-Aubert, Laure; Boccardi, Marina; Gietl, Anton; Picco, Agnese; Varrone, Andrea; Garibotto, Valentina; Herholz, Karl; Nobili, Flavio; Nordberg, Agneta (2017). 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, 52:214-227.

Abstract

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.

Abstract

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.

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Additional indexing

Contributors:Geneva Task Force for the Roadmap of Alzheimer's Biomarkers
Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Institute for Regenerative Medicine (IREM)
Dewey Decimal Classification:610 Medicine & health
Uncontrolled Keywords:Developmental Biology, Ageing, General Neuroscience, Geriatrics and Gerontology, Clinical Neurology
Language:English
Date:April 2017
Deposited On:01 Feb 2018 10:33
Last Modified:19 Aug 2018 13:39
Publisher:Elsevier
ISSN:0197-4580
OA Status:Closed
Publisher DOI:https://doi.org/10.1016/j.neurobiolaging.2016.07.012
PubMed ID:28317650
Project Information:
  • : FunderFP7
  • : Grant ID605817
  • : Project TitleHFAUTO - Human Factors of Automated Driving

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