A Randomized, Double-blind, Placebo-controlled Trial of Long-term (2-year) Treatment of Galantamine in Mild to Moderately-severe Alzheimer’s Disease

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-002780-27

Femme et Homme

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Extrait

Overall objective The overall objective of this study is to evaluate the benefit-risk of long-term (over the course of 2 years) treatment with galantamine as compared with placebo in subjects with mild to moderately-severe AD. Primary efficacy objective • Compare galantamine with placebo in cognitive change from baseline to Month 24 as measured by the MMSE score Primary safety objective Compare the rate of mortality between subjects randomly assigned to receive galantamine or matching placebo over the course of 2 years.


Critère d'inclusion

  • Mild to moderately severe Alzheimer's Disease