Universität zu Köln

Boccardi, Marina, Dodich, Alessandra, Albanese, Emiliano, Gayet-Ageron, Angele ORCID: 0000-0002-6164-9693, Festari, Cristina, Ashton, Nicholas J., Bischof, Gerard N., Chiotis, Konstantinos ORCID: 0000-0002-5679-0297, Leuzy, Antoine, Wolters, Emma E., Walter, Martin A., Rabinovici, Gil D., Carrillo, Maria, Drzezga, Alexander ORCID: 0000-0001-6018-716X, Hansson, Oskar ORCID: 0000-0001-8467-7286, Nordberg, Agneta, Ossenkoppele, Rik, Villemagne, Victor L., Winblad, Bengt, Frisoni, Giovanni B. and Garibotto, Valentina (2021). The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update. Eur. J. Nucl. Med. Mol. Imaging, 48 (7). S. 2070 - 2086. NEW YORK: SPRINGER. ISSN 1619-7089

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Abstract

Background The 2017 Alzheimer's disease (AD) Strategic Biomarker Roadmap (SBR) structured the validation of AD diagnostic biomarkers into 5 phases, systematically assessing analytical validity (Phases 1-2), clinical validity (Phases 3-4), and clinical utility (Phase 5) through primary and secondary Aims. This framework allows to map knowledge gaps and research priorities, accelerating the route towards clinical implementation. Within an initiative aimed to assess the development of biomarkers of tau pathology, we revised this methodology consistently with progress in AD research. Methods We critically appraised the adequacy of the 2017 Biomarker Roadmap within current diagnostic frameworks, discussed updates at a workshop convening the Alzheimer's Association and 8 leading AD biomarker research groups, and detailed the methods to allow consistent assessment of aims achievement for tau and other AD diagnostic biomarkers. Results The 2020 update applies to all AD diagnostic biomarkers. In Phases 2-3, we admitted a greater variety of study designs (e.g., cross-sectional in addition to longitudinal) and reference standards (e.g., biomarker confirmation in addition to clinical progression) based on construct (in addition to criterion) validity. We structured a systematic data extraction to enable transparent and formal evidence assessment procedures. Finally, we have clarified issues that need to be addressed to generate data eligible to evidence-to-decision procedures. Discussion This revision allows for more versatile and precise assessment of existing evidence, keeps up with theoretical developments, and helps clinical researchers in producing evidence suitable for evidence-to-decision procedures. Compliance with this methodology is essential to implement AD biomarkers efficiently in clinical research and diagnostics.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Boccardi, Marina UNSPECIFIED UNSPECIFIED UNSPECIFIED Dodich, Alessandra UNSPECIFIED UNSPECIFIED UNSPECIFIED Albanese, Emiliano UNSPECIFIED UNSPECIFIED UNSPECIFIED Gayet-Ageron, Angele UNSPECIFIED orcid.org/0000-0002-6164-9693 UNSPECIFIED Festari, Cristina UNSPECIFIED UNSPECIFIED UNSPECIFIED Ashton, Nicholas J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bischof, Gerard N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chiotis, Konstantinos UNSPECIFIED orcid.org/0000-0002-5679-0297 UNSPECIFIED Leuzy, Antoine UNSPECIFIED UNSPECIFIED UNSPECIFIED Wolters, Emma E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Walter, Martin A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rabinovici, Gil D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Carrillo, Maria UNSPECIFIED UNSPECIFIED UNSPECIFIED Drzezga, Alexander UNSPECIFIED orcid.org/0000-0001-6018-716X UNSPECIFIED Hansson, Oskar UNSPECIFIED orcid.org/0000-0001-8467-7286 UNSPECIFIED Nordberg, Agneta UNSPECIFIED UNSPECIFIED UNSPECIFIED Ossenkoppele, Rik UNSPECIFIED UNSPECIFIED UNSPECIFIED Villemagne, Victor L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Winblad, Bengt UNSPECIFIED UNSPECIFIED UNSPECIFIED Frisoni, Giovanni B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Garibotto, Valentina UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-606319
DOI:	10.1007/s00259-020-05120-2
Journal or Publication Title:	Eur. J. Nucl. Med. Mol. Imaging
Volume:	48
Number:	7
Page Range:	S. 2070 - 2086
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/60631