MAPT and Alzheimer disease: The EMA considered firstly that a pathological signature based on CSF Aβ42 and phospho-tau was acceptable for identifying prodromal-stage patients who are at risk of developing AD (European Medicines Agency, 2011b), secondly, using hippocampal volume (European Medicines Agency, 2011a), and thirdly, using amyloid PET as a biomarker to enrich pre-dementia trials (European Medicines Agency, 2011c).