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@ARTICLE{Ashton:155430,
      author       = {Ashton, N. J. and Leuzy, A. and Karikari, T. K. 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, Giovanni B and Garibotto, V. and Hansson, O.},
      title        = {{T}he validation status of blood biomarkers of amyloid and
                      phospho-tau assessed with the 5-phase development framework
                      for {AD} biomarkers.},
      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-2021-00636},
      pages        = {2140 - 2156},
      year         = {2021},
      abstract     = {The development of blood biomarkers that reflect
                      Alzheimer's disease (AD) pathophysiology (phosphorylated tau
                      and amyloid-β) has offered potential as scalable tests for
                      dementia differential diagnosis and early detection. In
                      2019, the Geneva AD Biomarker Roadmap Initiative included
                      blood biomarkers in the systematic validation of AD
                      biomarkers.A panel of experts convened in November 2019 at a
                      two-day workshop in Geneva. The level of maturity (fully
                      achieved, partly achieved, preliminary evidence, not
                      achieved, unsuccessful) of blood biomarkers was assessed
                      based on the Biomarker Roadmap methodology and discussed
                      fully during the workshop which also evaluated cerebrospinal
                      fluid (CSF) and positron emission tomography (PET)
                      biomarkers.Plasma p-tau has shown analytical validity (phase
                      2 primary aim 1) and first evidence of clinical validity
                      (phase 3 primary aim 1), whereas the maturity level for Aβ
                      remains to be partially achieved. Full and partial
                      achievement has been assigned to p-tau and Aβ,
                      respectively, in their associations to ante-mortem measures
                      (phase 2 secondary aim 2). However, only preliminary
                      evidence exists for the influence of covariates, assay
                      comparison and cut-off criteria.Despite the relative infancy
                      of blood biomarkers, in comparison to CSF biomarkers, much
                      has already been achieved for phases 1 through 3 - with
                      p-tau having greater success in detecting AD and predicting
                      disease progression. However, sufficient data about the
                      effect of covariates on the biomarker measurement is
                      lacking. No phase 4 (real-world performance) or phase 5
                      (assessment of impact/cost) aim has been tested, thus not
                      achieved.},
      subtyp        = {Review Article},
      keywords     = {Alzheimer Disease: diagnostic imaging / Amyloid
                      beta-Peptides / Biomarkers / Humans / Peptide Fragments /
                      Tomography, X-Ray Computed / tau Proteins / Alzheimer’s
                      disease (Other) / Aβ40 (Other) / Aβ42 (Other) / Blood
                      (Other) / P-tau (Other) / Strategic roadmap (Other) /
                      Amyloid beta-Peptides (NLM Chemicals) / Biomarkers (NLM
                      Chemicals) / Peptide Fragments (NLM Chemicals) / tau
                      Proteins (NLM Chemicals)},
      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:33677733},
      pmc          = {pmc:PMC8175325},
      doi          = {10.1007/s00259-021-05253-y},
      url          = {https://pub.dzne.de/record/155430},
}