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  • Boccardi, M.German Center for Neurodegenerative Diseases (DZNE), Greifswald,University of Geneva (author)

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

  • Article/chapterEnglish2021

Publisher, publication year, extent ...

  • 2021-03-10
  • Springer Science and Business Media LLC,2021

Numbers

  • LIBRIS-ID:oai:gup.ub.gu.se/306426
  • https://gup.ub.gu.se/publication/306426URI
  • https://doi.org/10.1007/s00259-020-05120-2DOI
  • https://lup.lub.lu.se/record/98224d39-1a6f-4015-921d-f5be6e2d9b8dURI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:146254335URI

Supplementary language notes

  • Language:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Dodich, A.University of Trento,University of Geneva (author)
  • Albanese, E.Università della Svizzera Italiana (author)
  • Gayet-Ageron, A.University of Geneva,Geneva University Hospital (author)
  • Festari, C.Centro San Giovanni di Dio Fatebenefratelli (author)
  • Ashton, Nicholas J.University of Gothenburg,Gothenburg University,Göteborgs universitet,Wallenberg Centre for Molecular and Translational Medicine,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry,South London and Maudsley NHS Foundation Trust,King's College London(Swepub:gu)xashtn (author)
  • Bischof, G. N.University Hospital of Cologne (author)
  • Chiotis, K.Karolinska Institutet,Karolinska Institute,Karolinska University Hospital (author)
  • Leuzy, AntoineKarolinska Institute(Swepub:lu)an3415le (author)
  • Wolters, E. E.Amsterdam UMC - Vrije Universiteit Amsterdam,Vrije Universiteit Amsterdam (author)
  • Walter, M. A.Geneva University Hospital (author)
  • Rabinovici, G. D.University of California, San Francisco (author)
  • Carrillo, M.Alzheimer's Association: Alzheimer's Disease and Dementia (author)
  • Drzezga, A.University of Cologne,German Center for Neurodegenerative Diseases (DZNE), Bonn,Jülich Research Centre (author)
  • Hansson, OskarLund University,Lunds universitet,Klinisk minnesforskning,Forskargrupper vid Lunds universitet,Clinical Memory Research,Lund University Research Groups,Skåne University Hospital(Swepub:lu)mphy-ohn (author)
  • Nordberg, A.Karolinska Institutet,Karolinska Institute,Karolinska University Hospital (author)
  • Ossenkoppele, RikLund University,Lunds universitet,Klinisk minnesforskning,Forskargrupper vid Lunds universitet,Clinical Memory Research,Lund University Research Groups,Vrije Universiteit Amsterdam,Amsterdam UMC - Vrije Universiteit Amsterdam(Swepub:lu)ri1513os (author)
  • Villemagne, V. L.Austin Health,University of Pittsburgh (author)
  • Winblad, B.Karolinska Institute,Karolinska University Hospital (author)
  • Frisoni, G. B.University of Geneva,Geneva University Hospital (author)
  • Garibotto, V.University of Geneva,Geneva University Hospital (author)
  • German Center for Neurodegenerative Diseases (DZNE), GreifswaldUniversity of Geneva (creator_code:org_t)

Related titles

  • In:European Journal of Nuclear Medicine and Molecular Imaging: Springer Science and Business Media LLC48, s. 2070-20851619-70701619-7089

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