Abstract | PURPOSE: METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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Authors | N J Ashton, A Leuzy, T K Karikari, N Mattsson-Carlgren, A Dodich, M Boccardi, J Corre, A Drzezga, A Nordberg, R Ossenkoppele, H Zetterberg, K Blennow, G B Frisoni, V Garibotto, O Hansson |
Journal | European journal of nuclear medicine and molecular imaging
(Eur J Nucl Med Mol Imaging)
Vol. 48
Issue 7
Pg. 2140-2156
(07 2021)
ISSN: 1619-7089 [Electronic] Germany |
PMID | 33677733
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review)
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Chemical References |
- Amyloid beta-Peptides
- Biomarkers
- Peptide Fragments
- tau Proteins
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Topics |
- Alzheimer Disease
(diagnostic imaging)
- Amyloid beta-Peptides
- Biomarkers
- Humans
- Peptide Fragments
- Tomography, X-Ray Computed
- tau Proteins
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