Draft qualification opinion of a novel data-driven model of disease progression and trial evaluation in mild and moderate Alzheimer’s disease

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Download document Draft qualification opinion of a novel data-driven model of disease progression and trial evaluation in mild and moderate Alzheimer’s disease
Reference number EMA/CHMP/SAWP/420174/2013
Status draft: consultation closed
First published 19/07/2013
Last updated 19/07/2013

Summary

The work described in this submission is intended to produce a tool that provides a common quantitative basis for the evaluation of study design and analysis methodologies for clinical studies in the mild and moderate Alzheimer's-disease population, with cognition as a primary endpoint.