An Evaluation of Three Doses of NS 2330 in Patients With Mild to Moderate Dementia of the Alzheimer's Type
Objectives: The objective of this study will be to determine the safety, tolerability, drug blood levels, and efficacy of each of three doses of NS 2330 (Tesofensine) given once daily compared with placebo in patients with mild to moderate Dementia of the Alzheimer's Type.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase II Double-Blind, Randomized, Placebo-Controlled, Multicenter, Safety and Efficacy Evaluation of Three Doses of NS 2330 in Patients With Probable Mild to Moderate Alzheimer's Disease|
- The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) will be used as the primary efficacy measure.
- The following assessments will be performed as secondary efficacy measures: ADCS-CGIC (clinical global impression of change ADCS-ADL (activities of daily living) NPI -neuropsych.inventory o MMSE o ADAS-Cog extension
|Study Start Date:||February 2003|
|Estimated Study Completion Date:||September 2005|
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|Study Chair:||Boehringer Ingelheim Study Coordinator||Boehringer Ingelheim Pharmaceuticals|