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https://ahro.austin.org.au/austinjspui/handle/1/26053| Title: | The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update. | Austin Authors: | Boccardi, Marina;Dodich, Alessandra;Albanese, Emiliano;Gayet-Ageron, Angèle;Festari, Cristina;Ashton, Nicholas J;Bischof, Gérard N;Chiotis, Konstantinos;Leuzy, Antoine;Wolters, Emma E;Walter, Martin A;Rabinovici, Gil D;Carrillo, Maria;Drzezga, Alexander;Hansson, Oskar;Nordberg, Agneta;Ossenkoppele, Rik;Villemagne, Victor L ;Winblad, Bengt;Frisoni, Giovanni B;Garibotto, Valentina | Affiliation: | Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK Department of Clinical Memory Research, Lund University, Lund, Sweden Department of Neurobiology, Care Sciences and Society, Division of Neurogeriatrics, Karolinska Institutet, Stockholm, Sweden LANE - Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsilvania, USA Departments of Neurology, Radiology & Biomedical Imaging, University of California, San Francisco, CA, USA Molecular Organization of the Brain, Research Center Jülich, Institute of Neuroscience and Medicine (INM-2), Julich, Germany Department of Nuclear Medicine, University Hospital Cologne, Cologne, Germany NIMTlab - Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland Nuclear Medicine and Molecular Division, Geneva Medical Hospital, Geneva, Switzerland LANVIE - Laboratory of Neuroimaging of Aging, University of Geneva, Geneva, Switzerland Memory Clinic, University Hospital, Geneva, Switzerland Karolinska University Hospital, Theme Aging, Geriatric Clinic, Huddinge, Sweden Molecular Imaging and Therapy Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, Netherlands Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden Clinical Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden Faculty of Medicine, University of Cologne, Cologne, Germany German Center for Neurodegenerative Diseases (DZNE), Bonn/Cologne, Germany Wallenberg Centre for Molecular and Translational Medicine, University of Gothenburg, Gothenburg, Sweden Department of Psychiatry and Neurochemistry, Institute of Neuroscience & Physiology, The Sahlgrenska Academy at The University of Gothenburg, Molndal, Sweden NIHR Biomedical Research Centre for Mental Health and Biomedical Research Unit for Dementia at South London and Maudsley NHS Foundation, London, UK Center for Neurocognitive Rehabilitation (CeRiN), CIMeC, University of Trento, Trento, Italy NIMTlab - Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland German Center for Neurodegenerative Diseases DZNE-Standort Rostock/Greifswald, Gehlsheimer Str. 20, 18147, Rostock, Germany LANVIE - Laboratory of Neuroimaging of Aging, University of Geneva, Geneva, Switzerland Alzheimer's Association, Chicago, IL, USA Theme Neurology, Karolinska University Hospital, Stockholm, Sweden Memory Clinic, Skåne University Hospital, Malmo, Sweden USI - Università della Svizzera Italiana, Institute of Public Health (IPH), Lugano, Switzerland Division of Clinical Epidemiology, Department of Health and Community Medicine, University of Geneva & University Hospitals of Geneva, Geneva, Switzerland Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, Netherlands Nuclear Medicine and Molecular Division, Geneva Medical Hospital, Geneva, Switzerland |
Issue Date: | Jul-2021 | Date: | 2021-03-10 | Publication information: | European Journal of Nuclear Medicine and Molecular Imaging 2021; 48(7): 2070-2085 | Abstract: | 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. 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. | URI: | https://ahro.austin.org.au/austinjspui/handle/1/26053 | DOI: | 10.1007/s00259-020-05120-2 | ORCID: | 0000-0001-6744-8246 | Journal: | European Journal of Nuclear Medicine and Molecular Imaging | PubMed URL: | 33688996 | Type: | Journal Article | Subjects: | Alzheimer’s disease Biomarker Dementia MCI Mild cognitive impairment Validation methodology |
| Appears in Collections: | Journal articles |
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