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000904295 0247_ $$2doi$$a10.1007/s00259-020-05156-4
000904295 0247_ $$2ISSN$$a0340-6997
000904295 0247_ $$2ISSN$$a1432-105X
000904295 0247_ $$2ISSN$$a1619-7070
000904295 0247_ $$2ISSN$$a1619-7089
000904295 0247_ $$2Handle$$a2128/32286
000904295 0247_ $$2pmid$$a33590274
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000904295 1001_ $$0P:(DE-Juel1)166265$$aBischof, Gerard Nisal$$b0$$eCorresponding author
000904295 245__ $$aClinical validity of second-generation tau PET tracers as biomarkers for Alzheimer’s disease in the context of a structured 5-phase development framework
000904295 260__ $$aHeidelberg [u.a.]$$bSpringer-Verl.$$c2021
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000904295 520__ $$aAbstractPurpose: In 2017, the Geneva Alzheimer's disease (AD) strategic biomarker roadmap initiative proposed a framework of the systematic validation AD biomarkers to harmonize and accelerate their development and implementation in clinical practice. Here, we use this framework to examine the translatability of the second-generation tau PET tracers into the clinical context.Methods: All available literature was systematically searched based on a set of search terms that related independently to analytic validity (phases 1-2), clinical validity (phase 3-4), and clinical utility (phase 5). The progress on each of the phases was determined based on scientific criteria applied for each phase and coded as fully, partially, preliminary achieved or not achieved at all.Results: The validation of the second-generation tau PET tracers has successfully passed the analytical phase 1 of the strategic biomarker roadmap. Assay definition studies showed evidence on the superiority over first-generation tau PET tracers in terms of off-target binding. Studies have partially achieved the primary aim of the analytical validity stage (phase 2), and preliminary evidence has been provided for the assessment of covariates on PET signal retention. Studies investigating of the clinical validity in phases 3, 4, and 5 are still underway.Conclusion: The current literature provides overall preliminary evidence on the establishment of the second-generation tau PET tracers into the clinical context, thereby successfully addressing some methodological issues from the tau PET tracer of the first generation. Nevertheless, bigger cohort studies, longitudinal follow-up, and examination of diverse disease population are still needed to gauge their clinical validity.Keywords: Alzheimer’s disease; Biomarker-based diagnosis; Second-generation tau PET tracers; Strategic roadmap.
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000904295 7001_ $$0P:(DE-HGF)0$$aDodich, Alessandra$$b1
000904295 7001_ $$0P:(DE-HGF)0$$aBoccardi, Marina$$b2
000904295 7001_ $$0P:(DE-HGF)0$$avan Eimeren, Thilo$$b3
000904295 7001_ $$0P:(DE-HGF)0$$aFestari, Cristina$$b4
000904295 7001_ $$0P:(DE-HGF)0$$aBarthel, Henryk$$b5
000904295 7001_ $$0P:(DE-HGF)0$$aHansson, Oskar$$b6
000904295 7001_ $$0P:(DE-HGF)0$$aNordberg, Agneta$$b7
000904295 7001_ $$0P:(DE-HGF)0$$aOssenkoppele, Rik$$b8
000904295 7001_ $$0P:(DE-HGF)0$$aSabri, Osama$$b9
000904295 7001_ $$0P:(DE-HGF)0$$aGiovanni, B Frisoni G$$b10
000904295 7001_ $$0P:(DE-HGF)0$$aGaribotto, Valentina$$b11
000904295 7001_ $$0P:(DE-Juel1)177611$$aDrzezga, Alexander$$b12
000904295 773__ $$0PERI:(DE-600)2098375-X$$a10.1007/s00259-020-05156-4$$gVol. 48, no. 7, p. 2110 - 2120$$n7$$p2110 - 2120$$tEuropean journal of nuclear medicine and molecular imaging$$v48$$x0340-6997$$y2021
000904295 8564_ $$uhttps://juser.fz-juelich.de/record/904295/files/s00259-020-05156-4.pdf$$yOpenAccess
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000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-Juel1)166265$$a  Department of Nuclear Medicine, University Hospital Cologne, Cologne, Germany. gerard.bischof@uk-koeln.de$$b0
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  NIMTlab, Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland$$b1
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Center for Neurocognitive Rehabilitation (CeRiN), CIMeC, University of Trento, Trento, Italy$$b1
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  German Center for Neurodegenerative Disorders (DZNE), Rostock/Greifswald, Rostock, Germany$$b2
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a German Center for Neurodegenerative Disorders (DZNE), Bonn/Cologne, Germany$$b2
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a German Center for Neurodegenerative Disorders (DZNE), Bonn/Cologne, Germany$$b3
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a German Center for Neurodegenerative Disorders (DZNE), Rostock/Greifswald, Rostock, Germany$$b3
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  Department of Nuclear Medicine, University Hospital Cologne, Cologne, Germany$$b3
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a LANE - Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy$$b4
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Department of Nuclear Medicine, University of Leipzig, Leipzig, Germany$$b5
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  Memory Clinic, Skåne University Hopsital, Malmö, Sweden$$b6
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Clinical Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden$$b6
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden$$b7
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Clinical Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden$$b8
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, Netherlands$$b8
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Department of Nuclear Medicine, University of Leipzig, Leipzig, Germany$$b9
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a NIMTlab, Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland$$b10
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Memory Center - Department of Rehabilitation and Geriatrics, Geneva University Hospitals, Geneva, Switzerland$$b10
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a  NIMTlab, Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland$$b11
000904295 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Nuclear Medicine and Molecular Imaging Division, Diagnostic Department, Geneva University Hospitals, Genève, Switzerland$$b11
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