Universität zu Köln

Bischof, Gerard N., Dodich, Alessandra, Boccardi, Marina, van Eimeren, Thilo ORCID: 0000-0002-6951-2325, Festari, Cristina, Barthel, Henryk, Hansson, Oskar ORCID: 0000-0001-8467-7286, Nordberg, Agneta, Ossenkoppele, Rik, Sabri, Osama, Giovanni, B. Frisoni G., Garibotto, Valentina and Drzezga, Alexander ORCID: 0000-0001-6018-716X (2021). Clinical validity of second-generation tau PET tracers 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. 2110 - 2121. NEW YORK: SPRINGER. ISSN 1619-7089

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Abstract

Purpose In 2017, the Geneva Alzheimer's disease (AD) strategic biomarker roadmap initiative proposed a framework of the systematic validation AD biomarkers to harmonize and accelerate their development and implementation in clinical practice. Here, we use this framework to examine the translatability of the second-generation tau PET tracers into the clinical context. Methods All available literature was systematically searched based on a set of search terms that related independently to analytic validity (phases 1-2), clinical validity (phase 3-4), and clinical utility (phase 5). The progress on each of the phases was determined based on scientific criteria applied for each phase and coded as fully, partially, preliminary achieved or not achieved at all. Results The validation of the second-generation tau PET tracers has successfully passed the analytical phase 1 of the strategic biomarker roadmap. Assay definition studies showed evidence on the superiority over first-generation tau PET tracers in terms of off-target binding. Studies have partially achieved the primary aim of the analytical validity stage (phase 2), and preliminary evidence has been provided for the assessment of covariates on PET signal retention. Studies investigating of the clinical validity in phases 3, 4, and 5 are still underway. Conclusion The current literature provides overall preliminary evidence on the establishment of the second-generation tau PET tracers into the clinical context, thereby successfully addressing some methodological issues from the tau PET tracer of the first generation. Nevertheless, bigger cohort studies, longitudinal follow-up, and examination of diverse disease population are still needed to gauge their clinical validity.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Bischof, Gerard N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dodich, Alessandra UNSPECIFIED UNSPECIFIED UNSPECIFIED Boccardi, Marina UNSPECIFIED UNSPECIFIED UNSPECIFIED van Eimeren, Thilo UNSPECIFIED orcid.org/0000-0002-6951-2325 UNSPECIFIED Festari, Cristina UNSPECIFIED UNSPECIFIED UNSPECIFIED Barthel, Henryk UNSPECIFIED UNSPECIFIED UNSPECIFIED Hansson, Oskar UNSPECIFIED orcid.org/0000-0001-8467-7286 UNSPECIFIED Nordberg, Agneta UNSPECIFIED UNSPECIFIED UNSPECIFIED Ossenkoppele, Rik UNSPECIFIED UNSPECIFIED UNSPECIFIED Sabri, Osama UNSPECIFIED UNSPECIFIED UNSPECIFIED Giovanni, B. Frisoni G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Garibotto, Valentina UNSPECIFIED UNSPECIFIED UNSPECIFIED Drzezga, Alexander UNSPECIFIED orcid.org/0000-0001-6018-716X UNSPECIFIED
URN:	urn:nbn:de:hbz:38-601288
DOI:	10.1007/s00259-020-05156-4
Journal or Publication Title:	Eur. J. Nucl. Med. Mol. Imaging
Volume:	48
Number:	7
Page Range:	S. 2110 - 2121
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/60128