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000904299 0247_ $$2doi$$a10.1007/s00259-021-05277-4
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000904299 0247_ $$2ISSN$$a1432-105X
000904299 0247_ $$2ISSN$$a1619-7070
000904299 0247_ $$2ISSN$$a1619-7089
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000904299 1001_ $$0P:(DE-HGF)0$$aChiotis, Konstantinos$$b0
000904299 245__ $$aClinical validity of increased cortical binding of tau ligands of the THK family and PBB3 on PET as biomarkers for Alzheimer’s disease in the context of a structured 5-phase development framework
000904299 260__ $$aHeidelberg [u.a.]$$bSpringer-Verl.$$c2021
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000904299 520__ $$aPurpose: 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.
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000904299 7001_ $$0P:(DE-HGF)0$$aDodich, Alessandra$$b1
000904299 7001_ $$0P:(DE-HGF)0$$aBoccardi, Marina$$b2
000904299 7001_ $$0P:(DE-HGF)0$$aFestari, Cristina$$b3
000904299 7001_ $$0P:(DE-Juel1)177611$$aDrzezga, Alexander$$b4
000904299 7001_ $$0P:(DE-HGF)0$$aHansson, Oskar$$b5
000904299 7001_ $$0P:(DE-HGF)0$$aOssenkoppele, Rik$$b6
000904299 7001_ $$0P:(DE-HGF)0$$aFrisoni, Giovanni$$b7
000904299 7001_ $$0P:(DE-HGF)0$$aGaribotto, Valentina$$b8
000904299 7001_ $$0P:(DE-HGF)0$$aNordberg, Agneta$$b9$$eCorresponding author
000904299 773__ $$0PERI:(DE-600)2098375-X$$a10.1007/s00259-021-05277-4$$gVol. 48, no. 7, p. 2086 - 2096$$n7$$p2086 - 2096$$tEuropean journal of nuclear medicine and molecular imaging$$v48$$x0340-6997$$y2021
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000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Nordberg Translational Molecular Imaging Lab, Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Neo 7th floor, 141 83, Stockholm, Sweden$$b0
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Department of Neurology, Karolinska University Hospital, Stockholm, Sweden$$b0
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  Center for Neurocognitive Rehabilitation (CeRiN), CIMeC, University of Trento, Trento, Italy$$b1
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a NIMTlab-Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland$$b1
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  German Center for Neurodegenerative Diseases (DZNE), Rostock, Germany$$b2
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  LANE-Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy$$b3
000904299 9101_ $$0I:(DE-588b)5008462-8$$6P:(DE-Juel1)177611$$aForschungszentrum Jülich$$b4$$kFZJ
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-Juel1)177611$$a Faculty of Medicine, University of Cologne, Cologne, Germany$$b4
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-Juel1)177611$$a  German Center for Neurodegenerative Diseases (DZNE), Bonn/Cologne, Germany$$b4
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Clinical Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden$$b5
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Memory Clinic, Skåne University Hospital, Malmö, Sweden$$b5
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, Netherlands$$b6
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Department of Clinical Memory Research, Lund University, Lund, Sweden$$b6
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  Memory Clinic, University Hospital, Geneva, Switzerland$$b7
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  German Center for Neurodegenerative Diseases (DZNE), Rostock, Germany$$b7
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  NIMTlab-Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland$$b8
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Nuclear Medicine and Molecular Division, Geneva Medical Hospital, Geneva, Switzerland$$b8
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Nordberg Translational Molecular Imaging Lab, Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Neo 7th floor, 141 83, Stockholm, Sweden. agneta.k.nordberg@ki.se.$$b9
000904299 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Theme Inflammation and Aging, Karolinska University Hospital, Stockholm, Sweden. agneta.k.nordberg@ki.se.$$b9
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