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000904297 1001_ $$0P:(DE-HGF)0$$aBoccardi, Marina$$b0$$eCorresponding author
000904297 245__ $$aThe strategic biomarker roadmap for the validation of Alzheimer’s diagnostic biomarkers: methodological update
000904297 260__ $$aHeidelberg [u.a.]$$bSpringer-Verl.$$c2021
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000904297 520__ $$aBackground: The 2017 Alzheimer's disease (AD) Strategic Biomarker Roadmap (SBR) structured the validation of AD diagnostic biomarkers into 5 phases, systematically assessing analytical validity (Phases 1-2), clinical validity (Phases 3-4), and clinical utility (Phase 5) through primary and secondary Aims. This framework allows to map knowledge gaps and research priorities, accelerating the route towards clinical implementation. Within an initiative aimed to assess the development of biomarkers of tau pathology, we revised this methodology consistently with progress in AD research.Methods: We critically appraised the adequacy of the 2017 Biomarker Roadmap within current diagnostic frameworks, discussed updates at a workshop convening the Alzheimer's Association and 8 leading AD biomarker research groups, and detailed the methods to allow consistent assessment of aims achievement for tau and other AD diagnostic biomarkers.Results: The 2020 update applies to all AD diagnostic biomarkers. In Phases 2-3, we admitted a greater variety of study designs (e.g., cross-sectional in addition to longitudinal) and reference standards (e.g., biomarker confirmation in addition to clinical progression) based on construct (in addition to criterion) validity. We structured a systematic data extraction to enable transparent and formal evidence assessment procedures. Finally, we have clarified issues that need to be addressed to generate data eligible to evidence-to-decision procedures.Discussion: This revision allows for more versatile and precise assessment of existing evidence, keeps up with theoretical developments, and helps clinical researchers in producing evidence suitable for evidence-to-decision procedures. Compliance with this methodology is essential to implement AD biomarkers efficiently in clinical research and diagnostics.Keywords: Alzheimer’s disease; Biomarker; Dementia; MCI; Mild cognitive impairment; Validation methodology.
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000904297 7001_ $$0P:(DE-HGF)0$$aDodich, Alessandra$$b1
000904297 7001_ $$0P:(DE-HGF)0$$aAlbanese, Emiliano$$b2
000904297 7001_ $$0P:(DE-HGF)0$$aGayet-Ageron, Angèle$$b3
000904297 7001_ $$0P:(DE-HGF)0$$aFestari, Cristina$$b4
000904297 7001_ $$0P:(DE-HGF)0$$aAshton, Nicholas J.$$b5
000904297 7001_ $$0P:(DE-HGF)0$$aBischof, Gérard N.$$b6
000904297 7001_ $$0P:(DE-HGF)0$$aChiotis, Konstantinos$$b7
000904297 7001_ $$0P:(DE-HGF)0$$aLeuzy, Antoine$$b8
000904297 7001_ $$0P:(DE-HGF)0$$aWolters, Emma E.$$b9
000904297 7001_ $$0P:(DE-HGF)0$$aWalter, Martin$$b10
000904297 7001_ $$0P:(DE-HGF)0$$aRabinovici, Gil D.$$b11
000904297 7001_ $$0P:(DE-HGF)0$$aCarrillo, Maria$$b12
000904297 7001_ $$0P:(DE-Juel1)177611$$aDrzezga, Alexander$$b13
000904297 7001_ $$0P:(DE-HGF)0$$aHansson, Oskar$$b14
000904297 7001_ $$0P:(DE-HGF)0$$aNordberg, Agneta$$b15
000904297 7001_ $$0P:(DE-HGF)0$$aOssenkoppele, Rik$$b16
000904297 7001_ $$0P:(DE-HGF)0$$aVillemagne, Victor L.$$b17
000904297 7001_ $$0P:(DE-HGF)0$$aWinblad, Bengt$$b18
000904297 7001_ $$0P:(DE-HGF)0$$aFrisoni, Giovanni$$b19
000904297 7001_ $$0P:(DE-HGF)0$$aGaribotto, Valentina$$b20
000904297 773__ $$0PERI:(DE-600)2098375-X$$a10.1007/s00259-021-05549-z$$gVol. 48, no. 13, p. 4525 - 4531$$n13$$p4525 - 4531$$tEuropean journal of nuclear medicine and molecular imaging$$v48$$x0340-6997$$y2021
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000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a German Center for Neurodegenerative Diseases DZNE-Standort Rostock/Greifswald, Gehlsheimer Str. 20, 18147, Rostock, Germany. marina.boccardi@dzne.de.$$b0
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a LANVIE - Laboratory of Neuroimaging of Aging, University of Geneva, Geneva, Switzerland. marina.boccardi@dzne.de$$b0
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Center for Neurocognitive Rehabilitation (CeRiN), CIMeC, University of Trento, Trento, Italy$$b1
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a NIMTlab - Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland$$b1
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a USI - Università della Svizzera Italiana, Institute of Public Health (IPH), Lugano, Switzerland$$b2
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Division of Clinical Epidemiology, Department of Health and Community Medicine, University of Geneva & University Hospitals of Geneva, Geneva, Switzerland$$b3
000904297 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
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Wallenberg Centre for Molecular and Translational Medicine, University of Gothenburg, Gothenburg, Sweden$$b5
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Department of Psychiatry and Neurochemistry, Institute of Neuroscience & Physiology, The Sahlgrenska Academy at The University of Gothenburg, Molndal, Sweden$$b5
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a NIHR Biomedical Research Centre for Mental Health and Biomedical Research Unit for Dementia at South London and Maudsley NHS Foundation, London, UK$$b5
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK$$b5
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Department of Nuclear Medicine, University Hospital Cologne, Cologne, Germany$$b6
000904297 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
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Theme Neurology, Karolinska University Hospital, Stockholm, Sweden$$b7
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden$$b8
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, Netherlands$$b9
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Nuclear Medicine and Molecular Division, Geneva Medical Hospital, Geneva, Switzerland$$b10
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Departments of Neurology, Radiology & Biomedical Imaging, University of California, San Francisco, CA, USA$$b11
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Alzheimer's Association, Chicago, IL, USA$$b12
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000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-Juel1)177611$$a Faculty of Medicine, University of Cologne, Cologne, Germany$$b13
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-Juel1)177611$$a German Center for Neurodegenerative Diseases (DZNE), Bonn/Cologne, Germany$$b13
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Clinical Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden$$b14
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Memory Clinic, Skåne University Hospital, Malmo, Sweden$$b14
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden$$b15
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000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, Netherlands$$b16
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Department of Clinical Memory Research, Lund University, Lund, Sweden$$b16
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsilvania, USA$$b17
000904297 9101_ $$0I:(DE-HGF)0$$6P:(DE-HGF)0$$a Department of Neurobiology, Care Sciences and Society, Division of Neurogeriatrics, Karolinska Institutet, Stockholm, Sweden$$b17
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