Please use this identifier to cite or link to this item: 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
metadata.dc.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
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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