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

Boccardi, Marina (författare)
University of Geneva,German Center for Neurodegenerative Diseases (DZNE), Greifswald
Dodich, Alessandra (författare)
University of Geneva,University of Trento
Albanese, Emiliano (författare)
University of Lugano
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Gayet-Ageron, Angèle (författare)
University of Geneva,Geneva University Hospital
Festari, Cristina (författare)
Centro San Giovanni di Dio Fatebenefratelli
Ashton, Nicholas J. (författare)
University of Gothenburg,King's College London,South London and Maudsley NHS Foundation Trust
Bischof, Gérard N. (författare)
University Hospital of Cologne
Chiotis, Konstantinos (författare)
Karolinska Institutet,Karolinska University Hospital
Leuzy, Antoine (författare)
Karolinska Institutet
Wolters, Emma E. (författare)
Amsterdam UMC - Vrije Universiteit Amsterdam,Vrije Universiteit Amsterdam
Walter, Martin A. (författare)
Geneva University Hospital
Rabinovici, Gil D. (författare)
University of California, San Francisco
Carrillo, Maria (författare)
Alzheimer's Association: Alzheimer's Disease and Dementia
Drzezga, Alexander (författare)
Jülich Research Centre,University of Cologne,German Center for Neurodegenerative Diseases (DZNE), Bonn
Hansson, Oskar (författare)
Lund University,Lunds universitet,Klinisk minnesforskning,Forskargrupper vid Lunds universitet,Clinical Memory Research,Lund University Research Groups,Skåne University Hospital
Nordberg, Agneta (författare)
Karolinska Institutet,Karolinska University Hospital
Ossenkoppele, Rik (författare)
Lund University,Lunds universitet,Klinisk minnesforskning,Forskargrupper vid Lunds universitet,Clinical Memory Research,Lund University Research Groups,Vrije Universiteit Amsterdam,Amsterdam UMC - Vrije Universiteit Amsterdam
Villemagne, Victor L. (författare)
University of Pittsburgh,Austin Health
Winblad, Bengt (författare)
Karolinska Institutet,Karolinska University Hospital
Frisoni, Giovanni B. (författare)
University of Geneva,Geneva University Hospital
Garibotto, Valentina (författare)
University of Geneva,Geneva University Hospital
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Springer, 2021
Ingår i: European Journal of Nuclear Medicine and Molecular Imaging. - : Springer. - 1619-7070.
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
  • 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.


MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Neurologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Neurology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)


Alzheimer’s disease
Mild cognitive impairment
Validation methodology

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