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@ARTICLE{Chiotis:904299,
author = {Chiotis, Konstantinos and Dodich, Alessandra and Boccardi,
Marina and Festari, Cristina and Drzezga, Alexander and
Hansson, Oskar and Ossenkoppele, Rik and Frisoni, Giovanni
and Garibotto, Valentina and Nordberg, Agneta},
title = {{C}linical validity of increased cortical binding of tau
ligands of the {THK} family and {PBB}3 on {PET} as
biomarkers for {A}lzheimer’s disease in the context of a
structured 5-phase development framework},
journal = {European journal of nuclear medicine and molecular imaging},
volume = {48},
number = {7},
issn = {0340-6997},
address = {Heidelberg [u.a.]},
publisher = {Springer-Verl.},
reportid = {FZJ-2021-05869},
pages = {2086 - 2096},
year = {2021},
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.Keywords: Alzheimer’s disease;
Biomarker-based diagnosis; PBB3; Strategic roadmap; THK; Tau
PET.},
cin = {INM-2},
ddc = {610},
cid = {I:(DE-Juel1)INM-2-20090406},
pnm = {5253 - Neuroimaging (POF4-525)},
pid = {G:(DE-HGF)POF4-5253},
typ = {PUB:(DE-HGF)16},
pubmed = {33723628},
UT = {WOS:000629198800001},
doi = {10.1007/s00259-021-05277-4},
url = {https://juser.fz-juelich.de/record/904299},
}