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@ARTICLE{Leuzy:155429,
      author       = {Leuzy, A. and Ashton, N. J. and Mattsson-Carlgren, N. and
                      Dodich, A. and Boccardi, M. and Corre, J. and Drzezga,
                      Alexander and Nordberg, A. and Ossenkoppele, R. and
                      Zetterberg, H. and Blennow, K. and Frisoni, G. B. and
                      Garibotto, V. and Hansson, O.},
      title        = {2020 update on the clinical validity of cerebrospinal fluid
                      amyloid, tau, and phospho-tau as biomarkers for
                      {A}lzheimer’s disease in the context of a structured
                      5-phase development framework},
      journal      = {European journal of nuclear medicine and molecular imaging},
      volume       = {48},
      number       = {7},
      issn         = {1619-7089},
      address      = {Heidelberg [u.a.]},
      publisher    = {Springer-Verl.},
      reportid     = {DZNE-2021-00635},
      pages        = {2121 - 2139},
      year         = {2021},
      abstract     = {Purpose: In the last decade, the research community has
                      focused on defining reliable biomarkers for the early
                      detection of Alzheimer's disease (AD) pathology. In 2017,
                      the Geneva AD Biomarker Roadmap Initiative adapted a
                      framework for the systematic validation of oncological
                      biomarkers to cerebrospinal fluid (CSF) AD
                      biomarkers-encompassing the 42 amino-acid isoform of
                      amyloid-β (Aβ42), phosphorylated-tau (P-tau), and
                      Total-tau (T-tau)-with the aim to accelerate their
                      development and clinical implementation. The aim of this
                      work is to update the current validation status of CSF AD
                      biomarkers based on the Biomarker Roadmap
                      methodology.Methods: A panel of experts in AD biomarkers
                      convened in November 2019 at a 2-day workshop in Geneva. The
                      level of maturity (fully achieved, partly achieved,
                      preliminary evidence, not achieved, unsuccessful) of CSF AD
                      biomarkers was assessed based on the Biomarker Roadmap
                      methodology before the meeting and presented and discussed
                      during the workshop.Results: By comparison to the previous
                      2017 Geneva Roadmap meeting, the primary advances in CSF AD
                      biomarkers have been in the area of a unified protocol for
                      CSF sampling, handling and storage, the introduction of
                      certified reference methods and materials for Aβ42, and the
                      introduction of fully automated assays. Additional advances
                      have occurred in the form of defining thresholds for
                      biomarker positivity and assessing the impact of covariates
                      on their discriminatory ability.Conclusions: Though much has
                      been achieved for phases one through three, much work
                      remains in phases four (real world performance) and five
                      (assessment of impact/cost). To a large degree, this will
                      depend on the availability of disease-modifying treatments
                      for AD, given these will make accurate and generally
                      available diagnostic tools key to initiate therapy.},
      subtyp        = {Review Article},
      keywords     = {Alzheimer Disease: diagnosis / Amyloid beta-Peptides /
                      Biomarkers / Humans / Peptide Fragments / tau Proteins},
      cin          = {AG Boccardi / Rostock / Greifswald common},
      ddc          = {610},
      cid          = {I:(DE-2719)5000062 / I:(DE-2719)6000017},
      pnm          = {353 - Clinical and Health Care Research (POF4-353)},
      pid          = {G:(DE-HGF)POF4-353},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:33674895},
      pubmed       = {33674895},
      pmc          = {pmc:PMC8175301},
      doi          = {10.1007/s00259-021-05258-7},
      url          = {https://pub.dzne.de/record/155429},
}