Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/26053
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dc.contributor.authorBoccardi, Marina-
dc.contributor.authorDodich, Alessandra-
dc.contributor.authorAlbanese, Emiliano-
dc.contributor.authorGayet-Ageron, Angèle-
dc.contributor.authorFestari, Cristina-
dc.contributor.authorAshton, Nicholas J-
dc.contributor.authorBischof, Gérard N-
dc.contributor.authorChiotis, Konstantinos-
dc.contributor.authorLeuzy, Antoine-
dc.contributor.authorWolters, Emma E-
dc.contributor.authorWalter, Martin A-
dc.contributor.authorRabinovici, Gil D-
dc.contributor.authorCarrillo, Maria-
dc.contributor.authorDrzezga, Alexander-
dc.contributor.authorHansson, Oskar-
dc.contributor.authorNordberg, Agneta-
dc.contributor.authorOssenkoppele, Rik-
dc.contributor.authorVillemagne, Victor L-
dc.contributor.authorWinblad, Bengt-
dc.contributor.authorFrisoni, Giovanni B-
dc.contributor.authorGaribotto, Valentina-
dc.date2021-03-10-
dc.date.accessioned2021-03-15T05:42:16Z-
dc.date.available2021-03-15T05:42:16Z-
dc.date.issued2021-03-10-
dc.identifier.citationEuropean Journal of Nuclear Medicine and Molecular Imaging 2021; online first: 10 Marchen
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/26053-
dc.description.abstractThe 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. 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. 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. 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.en
dc.language.isoeng
dc.subjectAlzheimer’s diseaseen
dc.subjectBiomarkeren
dc.subjectDementiaen
dc.subjectMCIen
dc.subjectMild cognitive impairmenten
dc.subjectValidation methodologyen
dc.titleThe strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update.en
dc.typeJournal Articleen
dc.identifier.journaltitleEuropean Journal of Nuclear Medicine and Molecular Imagingen
dc.identifier.affiliationInstitute of Psychiatry, Psychology & Neuroscience, King's College London, London, UKen
dc.identifier.affiliationDepartment of Clinical Memory Research, Lund University, Lund, Swedenen
dc.identifier.affiliationDepartment of Neurobiology, Care Sciences and Society, Division of Neurogeriatrics, Karolinska Institutet, Stockholm, Swedenen
dc.identifier.affiliationLANE - Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italyen
dc.identifier.affiliationDepartment of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsilvania, USAen
dc.identifier.affiliationDepartments of Neurology, Radiology & Biomedical Imaging, University of California, San Francisco, CA, USAen
dc.identifier.affiliationMolecular Organization of the Brain, Research Center Jülich, Institute of Neuroscience and Medicine (INM-2), Julich, Germanyen
dc.identifier.affiliationDepartment of Nuclear Medicine, University Hospital Cologne, Cologne, Germanyen
dc.identifier.affiliationNIMTlab - Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerlanden
dc.identifier.affiliationNuclear Medicine and Molecular Division, Geneva Medical Hospital, Geneva, Switzerlanden
dc.identifier.affiliationLANVIE - Laboratory of Neuroimaging of Aging, University of Geneva, Geneva, Switzerlanden
dc.identifier.affiliationMemory Clinic, University Hospital, Geneva, Switzerlanden
dc.identifier.affiliationKarolinska University Hospital, Theme Aging, Geriatric Clinic, Huddinge, Swedenen
dc.identifier.affiliationMolecular Imaging and Therapyen
dc.identifier.affiliationAlzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, Netherlandsen
dc.identifier.affiliationDivision of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Swedenen
dc.identifier.affiliationClinical Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Lund, Swedenen
dc.identifier.affiliationFaculty of Medicine, University of Cologne, Cologne, Germanyen
dc.identifier.affiliationGerman Center for Neurodegenerative Diseases (DZNE), Bonn/Cologne, Germanyen
dc.identifier.affiliationWallenberg Centre for Molecular and Translational Medicine, University of Gothenburg, Gothenburg, Swedenen
dc.identifier.affiliationDepartment of Psychiatry and Neurochemistry, Institute of Neuroscience & Physiology, The Sahlgrenska Academy at The University of Gothenburg, Molndal, Swedenen
dc.identifier.affiliationNIHR Biomedical Research Centre for Mental Health and Biomedical Research Unit for Dementia at South London and Maudsley NHS Foundation, London, UKen
dc.identifier.affiliationCenter for Neurocognitive Rehabilitation (CeRiN), CIMeC, University of Trento, Trento, Italyen
dc.identifier.affiliationNIMTlab - Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerlanden
dc.identifier.affiliationGerman Center for Neurodegenerative Diseases DZNE-Standort Rostock/Greifswald, Gehlsheimer Str. 20, 18147, Rostock, Germanyen
dc.identifier.affiliationLANVIE - Laboratory of Neuroimaging of Aging, University of Geneva, Geneva, Switzerlanden
dc.identifier.affiliationAlzheimer's Association, Chicago, IL, USAen
dc.identifier.affiliationTheme Neurology, Karolinska University Hospital, Stockholm, Swedenen
dc.identifier.affiliationMemory Clinic, Skåne University Hospital, Malmo, Swedenen
dc.identifier.affiliationUSI - Università della Svizzera Italiana, Institute of Public Health (IPH), Lugano, Switzerlanden
dc.identifier.affiliationDivision of Clinical Epidemiology, Department of Health and Community Medicine, University of Geneva & University Hospitals of Geneva, Geneva, Switzerlanden
dc.identifier.affiliationAlzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, Netherlandsen
dc.identifier.affiliationNuclear Medicine and Molecular Division, Geneva Medical Hospital, Geneva, Switzerlanden
dc.identifier.doi10.1007/s00259-020-05120-2en
dc.type.contentTexten
dc.identifier.orcid0000-0001-6744-8246en
dc.identifier.pubmedid33688996
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