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Clinical validity of second-generation tau PET tracers as biomarkers for Alzheimer’s disease in the context of a structured 5-phase development framework

Bischof, Gérard N. ; Dodich, Alessandra ; Boccardi, Marina ; van Eimeren, Thilo ; Festari, Cristina ; Barthel, Henryk ; Hansson, Oskar LU orcid ; Nordberg, Agneta ; Ossenkoppele, Rik LU and Sabri, Osama , et al. (2021) In European Journal of Nuclear Medicine and Molecular Imaging 48(7). p.2110-2120
Abstract

Purpose: 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... (More)

Purpose: 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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Alzheimer’s disease, Biomarker-based diagnosis, Second-generation tau PET tracers, Strategic roadmap
in
European Journal of Nuclear Medicine and Molecular Imaging
volume
48
issue
7
pages
11 pages
publisher
Springer
external identifiers
  • pmid:33590274
  • scopus:85101455686
ISSN
1619-7070
DOI
10.1007/s00259-020-05156-4
language
English
LU publication?
yes
id
0807754e-355c-4778-8398-b1d7710767cf
date added to LUP
2021-12-10 11:48:05
date last changed
2022-08-12 02:09:56
@article{0807754e-355c-4778-8398-b1d7710767cf,
  abstract     = {{<p>Purpose: 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.</p>}},
  author       = {{Bischof, Gérard N. 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}},
  issn         = {{1619-7070}},
  keywords     = {{Alzheimer’s disease; Biomarker-based diagnosis; Second-generation tau PET tracers; Strategic roadmap}},
  language     = {{eng}},
  number       = {{7}},
  pages        = {{2110--2120}},
  publisher    = {{Springer}},
  series       = {{European Journal of Nuclear Medicine and Molecular Imaging}},
  title        = {{Clinical validity of second-generation tau PET tracers as biomarkers for Alzheimer’s disease in the context of a structured 5-phase development framework}},
  url          = {{http://dx.doi.org/10.1007/s00259-020-05156-4}},
  doi          = {{10.1007/s00259-020-05156-4}},
  volume       = {{48}},
  year         = {{2021}},
}