Universität zu Köln

Leuzy, A., Ashton, N. J., Mattsson-Carlgren, N., Dodich, A., Boccardi, M., Corre, J., Drzezga, A., Nordberg, A., Ossenkoppele, R., Zetterberg, H., Blennow, K., Frisoni, G. B., Garibotto, V. and Hansson, O. (2021). 2020 update on the clinical validity of cerebrospinal fluid amyloid, tau, and phospho-tau as biomarkers for Alzheimer's disease in the context of a structured 5-phase development framework. Eur. J. Nucl. Med. Mol. Imaging, 48 (7). S. 2121 - 2140. NEW YORK: SPRINGER. ISSN 1619-7089

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Abstract

Purpose In the last decade, the research community has focused on defining reliable biomarkers for the early detection of Alzheimer's disease (AD) pathology. In 2017, the Geneva AD Biomarker Roadmap Initiative adapted a framework for the systematic validation of oncological biomarkers to cerebrospinal fluid (CSF) AD biomarkers-encompassing the 42 amino-acid isoform of amyloid-beta (A beta 42), phosphorylated-tau (P-tau), and Total-tau (T-tau)-with the aim to accelerate their development and clinical implementation. The aim of this work is to update the current validation status of CSF AD biomarkers based on the Biomarker Roadmap methodology. Methods A panel of experts in AD biomarkers convened in November 2019 at a 2-day workshop in Geneva. The level of maturity (fully achieved, partly achieved, preliminary evidence, not achieved, unsuccessful) of CSF AD biomarkers was assessed based on the Biomarker Roadmap methodology before the meeting and presented and discussed during the workshop. Results By comparison to the previous 2017 Geneva Roadmap meeting, the primary advances in CSF AD biomarkers have been in the area of a unified protocol for CSF sampling, handling and storage, the introduction of certified reference methods and materials for A beta 42, and the introduction of fully automated assays. Additional advances have occurred in the form of defining thresholds for biomarker positivity and assessing the impact of covariates on their discriminatory ability. Conclusions Though much has been achieved for phases one through three, much work remains in phases four (real world performance) and five (assessment of impact/cost). To a large degree, this will depend on the availability of disease-modifying treatments for AD, given these will make accurate and generally available diagnostic tools key to initiate therapy.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Leuzy, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ashton, N. J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mattsson-Carlgren, N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dodich, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Boccardi, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Corre, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Drzezga, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nordberg, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ossenkoppele, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zetterberg, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Blennow, K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Frisoni, G. B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Garibotto, V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hansson, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-604312
DOI:	10.1007/s00259-021-05258-7
Journal or Publication Title:	Eur. J. Nucl. Med. Mol. Imaging
Volume:	48
Number:	7
Page Range:	S. 2121 - 2140
Date:	2021
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1619-7089
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Radiology, Nuclear Medicine & Medical Imaging Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/60431