The validation status of blood biomarkers of amyloid and phospho-tau assessed with the 5-phase development framework for AD biomarkers.
Nicholas James AshtonA LeuzyT K KarikariN Mattsson-CarlgrenA DodichM BoccardiJ CorreA DrzezgaA NordbergR OssenkoppeleH ZetterbergK BlennowG B FrisoniV GaribottoO HanssonPublished in: European journal of nuclear medicine and molecular imaging (2021)
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.