TY  - JOUR
AU  - Bischof, Gerard Nisal
AU  - Dodich, Alessandra
AU  - Boccardi, Marina
AU  - van Eimeren, Thilo
AU  - Festari, Cristina
AU  - Barthel, Henryk
AU  - Hansson, Oskar
AU  - Nordberg, Agneta
AU  - Ossenkoppele, Rik
AU  - Sabri, Osama
AU  - Giovanni, B Frisoni G
AU  - Garibotto, Valentina
AU  - Drzezga, Alexander
TI  - Clinical validity of second-generation tau PET tracers as biomarkers for Alzheimer’s disease in the context of a structured 5-phase development framework
JO  - European journal of nuclear medicine and molecular imaging
VL  - 48
IS  - 7
SN  - 0340-6997
CY  - Heidelberg [u.a.]
PB  - Springer-Verl.
M1  - FZJ-2021-05865
SP  - 2110 - 2120
PY  - 2021
AB  - AbstractPurpose: 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.Keywords: Alzheimer’s disease; Biomarker-based diagnosis; Second-generation tau PET tracers; Strategic roadmap.
LB  - PUB:(DE-HGF)16
C6  - 33590274
UR  - <Go to ISI:>//WOS:000618156900001
DO  - DOI:10.1007/s00259-020-05156-4
UR  - https://juser.fz-juelich.de/record/904295
ER  -