Universität zu Köln

Chiotis, Konstantinos ORCID: 0000-0002-5679-0297, Dodich, Alessandra, Boccardi, Marina, Festari, Cristina, Drzezga, Alexander ORCID: 0000-0001-6018-716X, Hansson, Oskar ORCID: 0000-0001-8467-7286, Ossenkoppele, Rik, Frisoni, Giovanni, Garibotto, Valentina and Nordberg, Agneta (2021). Clinical validity of increased cortical binding of tau ligands of the THK family and PBB3 on PET 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. 2086 - 2097. NEW YORK: SPRINGER. ISSN 1619-7089

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Abstract

Purpose The research community has focused on defining reliable biomarkers for the early detection of the pathological hallmarks of Alzheimer's disease (AD). In 2017, the Geneva AD Biomarker Roadmap initiative adapted the framework for the systematic validation of oncological biomarkers to AD, with the aim to accelerate their development and implementation in clinical practice. The aim of this work was to assess the validation status of tau PET ligands of the THK family and PBB3 as imaging biomarkers for AD, 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 clinical validity of tau PET ligands of the THK family and PBB3 was assessed based on the 5-phase development framework before the meeting and discussed during the workshop. Results PET radioligands of the THK family discriminate well between healthy controls and patients with AD dementia (phase 2; partly achieved) and recent evidence suggests an accurate diagnostic accuracy at the mild cognitive impairment (MCI) stage of the disease (phase 3; partly achieved). The phases 2 and 3 were considered not achieved for PBB3 since no evidence exists about the ligand's diagnostic accuracy. Preliminary evidence exists about the secondary aims of each phase for all ligands. Conclusion Much work remains for completing the aims of phases 2 and 3 and replicating the available evidence. However, it is unlikely that the validation process for these tracers will be completed, given the presence of off-target binding and the development of second-generation tracers with improved binding and pharmacokinetic properties.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Chiotis, Konstantinos UNSPECIFIED orcid.org/0000-0002-5679-0297 UNSPECIFIED Dodich, Alessandra UNSPECIFIED UNSPECIFIED UNSPECIFIED Boccardi, Marina UNSPECIFIED UNSPECIFIED UNSPECIFIED Festari, Cristina UNSPECIFIED UNSPECIFIED UNSPECIFIED Drzezga, Alexander UNSPECIFIED orcid.org/0000-0001-6018-716X UNSPECIFIED Hansson, Oskar UNSPECIFIED orcid.org/0000-0001-8467-7286 UNSPECIFIED Ossenkoppele, Rik UNSPECIFIED UNSPECIFIED UNSPECIFIED Frisoni, Giovanni UNSPECIFIED UNSPECIFIED UNSPECIFIED Garibotto, Valentina UNSPECIFIED UNSPECIFIED UNSPECIFIED Nordberg, Agneta UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-602315
DOI:	10.1007/s00259-021-05277-4
Journal or Publication Title:	Eur. J. Nucl. Med. Mol. Imaging
Volume:	48
Number:	7
Page Range:	S. 2086 - 2097
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/60231