EMA: Qualification opinion of Alzheimer’s disease novel methodologies/biomarkers in predementia AD clinical trials

In follow-up to the positive Qualification Opinion on the use of cerebrospinal fluid (CSF) biomarkers in predementia AD adopted on 14-Apr-2011 (EMA/CHMP/SAWP/102001/2011), BMS is requesting an additional qualification advice and ultimately, a qualification opinion, on an additional biomarker [amyloid positron emission tomography (PET) imaging)] for patient selection in both predementia and mild to moderately severe AD clinical studies, and to expand the positive Qualification Opinion on CSF biomarkers in predementia AD for application in clinical studies of amyloid-targeted therapies in mild to moderately severe AD.

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