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Title

Clinical validity of increased cortical uptake of [18F]flortaucipir on PET as a biomarker for Alzheimer's disease in the context of a structured 5-phase biomarker development framework

Authors
Wolters, E E
Boccardi, M
Drzezga, A
Hansson, O
Nordberg, A
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Published in European journal of nuclear medicine and molecular imaging. 2021, vol. 48, no. 7, p. 2097-2109
Abstract Purpose: In 2017, the Geneva Alzheimer's disease (AD) Biomarker Roadmap initiative adapted the framework of the systematic validation of oncological diagnostic biomarkers to AD biomarkers, with the aim to accelerate their development and implementation in clinical practice. With this work, we assess the maturity of [18F]flortaucipir PET and define its research priorities. Methods: The level of maturity of [18F]flortaucipir was assessed based on the AD Biomarker Roadmap. The framework assesses analytical validity (phases 1-2), clinical validity (phases 3-4), and clinical utility (phase 5). Results: The main aims of phases 1 (rationale for use) and 2 (discriminative ability) have been achieved. [18F]Flortaucipir binds with high affinity to paired helical filaments of tau and has favorable kinetic properties and excellent discriminative accuracy for AD. The majority of secondary aims of phase 2 were fully achieved. Multiple studies showed high correlations between ante-mortem [18F]flortaucipir PET and post-mortem tau (as assessed by histopathology), and also the effects of covariates on tracer binding are well studied. The aims of phase 3 (early detection ability) were only partially or preliminarily achieved, and the aims of phases 4 and 5 were not achieved. Conclusion: Current literature provides partial evidence for clinical utility of [18F]flortaucipir PET. The aims for phases 1 and 2 were mostly achieved. Phase 3 studies are currently ongoing. Future studies including representative MCI populations and a focus on healthcare outcomes are required to establish full maturity of phases 4 and 5.
Keywords Alzheimer’s diseaseBiomarker-based diagnosisPETStrategic roadmap[18F]flortaucipirAlzheimer Disease / diagnostic imagingBiomarkersCarbolinesHumansPositron-Emission TomographyTau Proteins
Identifiers
PMID: 33547556
PMCID: PMC8175307
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Structures
Research groups Troubles de mémoire et maladie d'Alzeimer (935)
Laboratoire de neuroimagerie et de traceurs moléculaires innovants (984)
Project
FNS: 188355
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WOLTERS, E E et al. Clinical validity of increased cortical uptake of [18F]flortaucipir on PET as a biomarker for Alzheimer's disease in the context of a structured 5-phase biomarker development framework. In: European journal of nuclear medicine and molecular imaging, 2021, vol. 48, n° 7, p. 2097-2109. doi: 10.1007/s00259-020-05118-w https://archive-ouverte.unige.ch/unige:160864

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Deposited on : 2022-05-16

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