Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease

Background: Regulatory qualification of a biomarker for a defined context of use provides scientifically robustassurances to sponsors and regulators that accelerate appropriate adoption of biomarkers into drug development. Methods: The Coalition Against Major Diseases submitted a dossier to the Scientific Advice Working Party of the European Medicines Agency requesting a qualification opinion on the use of hippocampalvolumeasabiomarkerforenrichingclinicaltrialsinsubjectswithmildcognitiveimpairment, incorporating a scientific rationale, a literature review and a de novo analysis of Alzheimer’s Disease Neuroimaging Initiative data.