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Sökning: onr:"swepub:oai:lup.lub.lu.se:98224d39-1a6f-4015-921d-f5be6e2d9b8d" > The strategic bioma...

  • Boccardi, MarinaUniversity of Geneva,German Center for Neurodegenerative Diseases (DZNE), Greifswald (författare)

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

  • Artikel/kapitelEngelska2021

Förlag, utgivningsår, omfång ...

  • Springer,2021

Nummerbeteckningar

  • LIBRIS-ID:oai:lup.lub.lu.se:98224d39-1a6f-4015-921d-f5be6e2d9b8d
  • https://lup.lub.lu.se/record/98224d39-1a6f-4015-921d-f5be6e2d9b8dURI
  • https://doi.org/10.1007/s00259-020-05120-2DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

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Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • 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.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Dodich, AlessandraUniversity of Geneva,University of Trento (författare)
  • Albanese, EmilianoUniversity of Lugano (författare)
  • Gayet-Ageron, AngèleUniversity of Geneva,Geneva University Hospital (författare)
  • Festari, CristinaCentro San Giovanni di Dio Fatebenefratelli (författare)
  • Ashton, Nicholas J.University of Gothenburg,King's College London,South London and Maudsley NHS Foundation Trust (författare)
  • Bischof, Gérard N.University Hospital of Cologne (författare)
  • Chiotis, KonstantinosKarolinska Institutet,Karolinska University Hospital (författare)
  • Leuzy, AntoineKarolinska Institutet(Swepub:lu)an3415le (författare)
  • Wolters, Emma E.Amsterdam UMC - Vrije Universiteit Amsterdam,Vrije Universiteit Amsterdam (författare)
  • Walter, Martin A.Geneva University Hospital (författare)
  • Rabinovici, Gil D.University of California, San Francisco (författare)
  • Carrillo, MariaAlzheimer's Association: Alzheimer's Disease and Dementia (författare)
  • Drzezga, AlexanderJülich Research Centre,University of Cologne,German Center for Neurodegenerative Diseases (DZNE), Bonn (författare)
  • 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 (författare)
  • Nordberg, AgnetaKarolinska Institutet,Karolinska University Hospital (författare)
  • 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 (författare)
  • Villemagne, Victor L.University of Pittsburgh,Austin Health (författare)
  • Winblad, BengtKarolinska Institutet,Karolinska University Hospital (författare)
  • Frisoni, Giovanni B.University of Geneva,Geneva University Hospital (författare)
  • Garibotto, ValentinaUniversity of Geneva,Geneva University Hospital (författare)
  • University of GenevaGerman Center for Neurodegenerative Diseases (DZNE), Greifswald (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:European Journal of Nuclear Medicine and Molecular Imaging: Springer1619-7070

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