The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update.

Alzheimer Disease / diagnosis Amyloid beta-Peptides Biomarkers Cognitive Dysfunction Cross-Sectional Studies Disease Progression Humans Reference Standards tau Proteins
Alzheimer’s disease Biomarker Dementia MCI Mild cognitive impairment Validation methodology

Journal

European journal of nuclear medicine and molecular imaging
ISSN: 1619-7089
Titre abrégé: Eur J Nucl Med Mol Imaging
Pays: Germany
ID NLM: 101140988

Informations de publication

Date de publication:
07 2021
Historique:
received: 25 09 2020
accepted: 15 11 2020
pubmed: 11 3 2021
medline: 29 6 2021
entrez: 10 3 2021
Statut: ppublish

Résumé

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.

Sections du résumé

BACKGROUND
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.

Identifiants

DOI: 10.1007/s00259-020-05120-2 PMID: 33688996 PMC: PMC8175304
pubmed: 33688996
doi: 10.1007/s00259-020-05120-2
pii: 10.1007/s00259-020-05120-2
pmc: PMC8175304
doi:

Substances chimiques

Amyloid beta-Peptides 0
Biomarkers 0
tau Proteins 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2070-2085

Subventions

Organisme : Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
ID : IZSEZ0_188355
Organisme : Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
ID : 320030_169876
Organisme : Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
ID : 320030_185028
Organisme : Innovative Medicines Initiative
ID : 115952

Commentaires et corrections

Type : ErratumIn

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Auteurs

Marina Boccardi (M)

German Center for Neurodegenerative Diseases DZNE-Standort Rostock/Greifswald, Gehlsheimer Str. 20, 18147, Rostock, Germany. marina.boccardi@dzne.de.
LANVIE - Laboratory of Neuroimaging of Aging, University of Geneva, Geneva, Switzerland. marina.boccardi@dzne.de.
ORCID: 0000-0001-6744-8246

Alessandra Dodich (A)

Center for Neurocognitive Rehabilitation (CeRiN), CIMeC, University of Trento, Trento, Italy.
NIMTlab - Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland.

Emiliano Albanese (E)

USI - Università della Svizzera Italiana, Institute of Public Health (IPH), Lugano, Switzerland.

Angèle Gayet-Ageron (A)

Division of Clinical Epidemiology, Department of Health and Community Medicine, University of Geneva & University Hospitals of Geneva, Geneva, Switzerland.

Cristina Festari (C)

LANE - Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.

Nicholas J Ashton (NJ)

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.
Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.

Gérard N Bischof (GN)

Department of Nuclear Medicine, University Hospital Cologne, Cologne, Germany.

Konstantinos Chiotis (K)

Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.
Theme Neurology, Karolinska University Hospital, Stockholm, Sweden.

Antoine Leuzy (A)

Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.

Emma E Wolters (EE)

Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.

Martin A Walter (MA)

Nuclear Medicine and Molecular Division, Geneva Medical Hospital, Geneva, Switzerland.

Gil D Rabinovici (GD)

Departments of Neurology, Radiology & Biomedical Imaging, University of California, San Francisco, CA, USA.

Maria Carrillo (M)

Alzheimer's Association, Chicago, IL, USA.

Alexander Drzezga (A)

Faculty of Medicine, University of Cologne, Cologne, Germany.
German Center for Neurodegenerative Diseases (DZNE), Bonn/Cologne, Germany.
Molecular Organization of the Brain, Research Center Jülich, Institute of Neuroscience and Medicine (INM-2), Julich, Germany.

Oskar Hansson (O)

Clinical Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden.
Memory Clinic, Skåne University Hospital, Malmo, Sweden.

Agneta Nordberg (A)

Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.
Karolinska University Hospital, Theme Aging, Geriatric Clinic, Huddinge, Sweden.

Rik Ossenkoppele (R)

Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.
Department of Clinical Memory Research, Lund University, Lund, Sweden.

Victor L Villemagne (VL)

Department of Molecular Imaging & Therapy, Austin Health, Melbourne, VIC, Australia.
Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsilvania, USA.

Bengt Winblad (B)

Karolinska University Hospital, Theme Aging, Geriatric Clinic, Huddinge, Sweden.
Department of Neurobiology, Care Sciences and Society, Division of Neurogeriatrics, Karolinska Institutet, Stockholm, Sweden.

Giovanni B Frisoni (GB)

LANVIE - Laboratory of Neuroimaging of Aging, University of Geneva, Geneva, Switzerland.
Memory Clinic, University Hospital, Geneva, Switzerland.

Valentina Garibotto (V)

NIMTlab - Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland.
Nuclear Medicine and Molecular Division, Geneva Medical Hospital, Geneva, Switzerland.

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questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Protéines membranaires › Peptides bêta-amyloïdes › The strategic biomarker roadmap for the...
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questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Protéines de tissu nerveux › Protéines associées aux microtubules › Protéines tau › The strategic biomarker roadmap for the...