Primary: This study is being conducted to evaluate if AVE1625 is safe and tolerated in patients with Alzheimer's disease that is not too severe. There is also evaluation of whether patients who take the study medication improve compared to patients who take a placebo (sugar pill). Secondary:The study will also evaluate the blood levels of the study medication, AVE1625 in patients who join the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
162
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Milan, Italy
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Safety and tolerability throughout the study:adverse events collected by spontaneous report
physical examination and neurological assessment
vital sign monitoring, clinical laboratories, and ECGs.
Efficacy variables:measures of change in cognition, global functioning and behavior at week 12.
Pharmacokinetic parameters will be assessed throughout the 12-week treatment period.
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Sanofi-Aventis Administrative Office
Bromma, Sweden