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@ARTICLE{Bischof:904295,
      author       = {Bischof, Gerard Nisal and Dodich, Alessandra and Boccardi,
                      Marina and van Eimeren, Thilo and Festari, Cristina and
                      Barthel, Henryk and Hansson, Oskar and Nordberg, Agneta and
                      Ossenkoppele, Rik and Sabri, Osama and Giovanni, B Frisoni G
                      and Garibotto, Valentina and Drzezga, Alexander},
      title        = {{C}linical validity of second-generation tau {PET} tracers
                      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         = {0340-6997},
      address      = {Heidelberg [u.a.]},
      publisher    = {Springer-Verl.},
      reportid     = {FZJ-2021-05865},
      pages        = {2110 - 2120},
      year         = {2021},
      abstract     = {AbstractPurpose: In 2017, the Geneva Alzheimer's disease
                      (AD) strategic biomarker roadmap initiative proposed a
                      framework of the systematic validation AD biomarkers to
                      harmonize and accelerate their development and
                      implementation in clinical practice. Here, we use this
                      framework to examine the translatability of the
                      second-generation tau PET tracers into the clinical
                      context.Methods: All available literature was systematically
                      searched based on a set of search terms that related
                      independently to analytic validity (phases 1-2), clinical
                      validity (phase 3-4), and clinical utility (phase 5). The
                      progress on each of the phases was determined based on
                      scientific criteria applied for each phase and coded as
                      fully, partially, preliminary achieved or not achieved at
                      all.Results: The validation of the second-generation tau PET
                      tracers has successfully passed the analytical phase 1 of
                      the strategic biomarker roadmap. Assay definition studies
                      showed evidence on the superiority over first-generation tau
                      PET tracers in terms of off-target binding. Studies have
                      partially achieved the primary aim of the analytical
                      validity stage (phase 2), and preliminary evidence has been
                      provided for the assessment of covariates on PET signal
                      retention. Studies investigating of the clinical validity in
                      phases 3, 4, and 5 are still underway.Conclusion: The
                      current literature provides overall preliminary evidence on
                      the establishment of the second-generation tau PET tracers
                      into the clinical context, thereby successfully addressing
                      some methodological issues from the tau PET tracer of the
                      first generation. Nevertheless, bigger cohort studies,
                      longitudinal follow-up, and examination of diverse disease
                      population are still needed to gauge their clinical
                      validity.Keywords: Alzheimer’s disease; Biomarker-based
                      diagnosis; Second-generation tau PET tracers; Strategic
                      roadmap.},
      cin          = {INM-2},
      ddc          = {610},
      cid          = {I:(DE-Juel1)INM-2-20090406},
      pnm          = {5253 - Neuroimaging (POF4-525)},
      pid          = {G:(DE-HGF)POF4-5253},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {33590274},
      UT           = {WOS:000618156900001},
      doi          = {10.1007/s00259-020-05156-4},
      url          = {https://juser.fz-juelich.de/record/904295},
}