Qualification opinion of Alzheimer’s disease novel methodologies / biomarkers for the use of cerebrospinal-fluid amyloid beta 1-42 and t-tau signature and / or positron-emission-tomography amyloid imaging (positive / negative) as a biomarkers for enrichment for use in regulatory clinical trials in mild and moderate Alzheimer’s disease

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Summary

In follow-up to the positive qualification opinion on the use of cerebrospinal fluid (CSF) biomarkers in predementia Alzheimer's disease adopted on 14 April 2011 (EMA/CHMP/SAWP/102001/2011).