A Phase II Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled, Multicenter, Safety and Efficacy Evaluation of Three Doses of NS 2330 in Patients With Mild to Moderate Dementia of the Alzheimer's Type

简要总结

主要结局

次要结局

• Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change(weeks 0 and 14)
• Alzheimer's Disease Cooperative Study-Activities of Daily Living(weeks 0, 4, and 14)
• Neuropsychiatric Inventory(weeks 0, 4, and 14)
• Mini-Mental State Examination(weeks 0 and 14)
• ADAS-Cog Extension(weeks 0, 4, 9, 14 and 20)
• ADAS-Cog total score including Extension(weeks 0, 4, and 14)
• types and frequencies of adverse events(20 weeks)
• proportion of patients discontinued from the trial because of adverse events(20 weeks)
• changes from baseline in vital signs(20 weeks)
• changes from baseline in laboratory measurements(20 weeks)
• changes from baseline in ECG readings(20 weeks)
• comparison of study groups for drug plasma concentrations(weeks 0, 4, 9, 14 and 20)
• population PK parameters(Weeks 0, 4, 9, 14 and 20)