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000904375 0247_ $$2ISSN$$a1619-7089
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000904375 1001_ $$0P:(DE-HGF)0$$aWolters, E. E.$$b0$$eCorresponding author
000904375 245__ $$aClinical validity of increased cortical uptake of [18F]flortaucipir on PET as a biomarker for Alzheimer’s disease in the context of a structured 5-phase biomarker development framework
000904375 260__ $$aHeidelberg [u.a.]$$bSpringer-Verl.$$c2021
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000904375 520__ $$aPurpose: In 2017, the Geneva Alzheimer's disease (AD) Biomarker Roadmap initiative adapted the framework of the systematic validation of oncological diagnostic biomarkers to AD biomarkers, with the aim to accelerate their development and implementation in clinical practice. With this work, we assess the maturity of [18F]flortaucipir PET and define its research priorities.Methods: The level of maturity of [18F]flortaucipir was assessed based on the AD Biomarker Roadmap. The framework assesses analytical validity (phases 1-2), clinical validity (phases 3-4), and clinical utility (phase 5).Results: The main aims of phases 1 (rationale for use) and 2 (discriminative ability) have been achieved. [18F]Flortaucipir binds with high affinity to paired helical filaments of tau and has favorable kinetic properties and excellent discriminative accuracy for AD. The majority of secondary aims of phase 2 were fully achieved. Multiple studies showed high correlations between ante-mortem [18F]flortaucipir PET and post-mortem tau (as assessed by histopathology), and also the effects of covariates on tracer binding are well studied. The aims of phase 3 (early detection ability) were only partially or preliminarily achieved, and the aims of phases 4 and 5 were not achieved.Conclusion: Current literature provides partial evidence for clinical utility of [18F]flortaucipir PET. The aims for phases 1 and 2 were mostly achieved. Phase 3 studies are currently ongoing. Future studies including representative MCI populations and a focus on healthcare outcomes are required to establish full maturity of phases 4 and 5.Keywords: Alzheimer’s disease; Biomarker-based diagnosis; PET; Strategic roadmap; [18F]flortaucipir.
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000904375 7001_ $$0P:(DE-HGF)0$$aDodich, A.$$b1
000904375 7001_ $$0P:(DE-HGF)0$$aBoccardi, M.$$b2
000904375 7001_ $$0P:(DE-HGF)0$$aCorre, J.$$b3
000904375 7001_ $$0P:(DE-Juel1)177611$$aDrzezga, Alexander$$b4
000904375 7001_ $$0P:(DE-HGF)0$$aHansson, O.$$b5
000904375 7001_ $$0P:(DE-HGF)0$$aNordberg, A.$$b6
000904375 7001_ $$0P:(DE-HGF)0$$aFrisoni, G. B.$$b7
000904375 7001_ $$0P:(DE-HGF)0$$aGaribotto, V.$$b8
000904375 7001_ $$0P:(DE-HGF)0$$aOssenkoppele, R.$$b9
000904375 773__ $$0PERI:(DE-600)2098375-X$$a10.1007/s00259-020-05118-w$$gVol. 48, no. 7, p. 2097 - 2109$$n7$$p2097 - 2109$$tEuropean journal of nuclear medicine and molecular imaging$$v48$$x0340-6997$$y2021
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000904375 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  Department of Radiology & Nuclear Medicine, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, location VUmc, PO Box 7057, 1007 MB, Amsterdam, The Netherlands. e.e.wolters-2@umcutrecht.nl$$b0
000904375 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands. e.e.wolters-2@umcutrecht.nl$$b0
000904375 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  NIMTlab - Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland$$b1
000904375 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Centre for Mind/Brain Sciences-CIMeC, University of Trento, Rovereto, Italy$$b1
000904375 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  Late Translational Dementia Studies Group, German Center for Neurodegenerative Diseases (DZNE), Rostock-Greifswald site, Rostock, Germany$$b2
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000904375 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a CURIC, Centre Universitaire Romand d'Implants Cochléaires, Department of Clinical Neurosciences, University of Geneva, Geneva, Switzerland$$b3
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000904375 9101_ $$0I:(DE-HGF)0$$6P:(DE-Juel1)177611$$a Faculty of Medicine, University of Cologne, Cologne, Germany$$b4
000904375 9101_ $$0I:(DE-HGF)0$$6P:(DE-Juel1)177611$$a  German Center for Neurodegenerative Diseases (DZNE), Bonn-Cologne, Germany$$b4
000904375 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Memory Clinic, Skåne University Hospital, Malmö, Sweden$$b5
000904375 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Clinical Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden$$b5
000904375 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden$$b6
000904375 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a LANVIE - Laboratory of Neuroimaging of Aging, University of Geneva, Geneva, Switzerland$$b7
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