MAPT and dementia: However, despite the initial EMA opinion on the CSF biomarkers positive signature, which includes low Aβ1-42 and high p-tau concentrations, as a predictor for dementia evolution in individuals with MCI (https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-alzheimers-disease-novel-methodologies/biomarkers-use-cerebrospinal-fluid-amyloid-beta-1-42-t-tau-signature/positron-emission-tomography-amyloid-imaging-positive), only a small number of biomarkers have undergone a formal regulatory process for qualification.