An Evaluation of Three Doses of NS 2330 in Patients With Mild to Moderate Dementia of the Alzheimer's Type
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00153010
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 430
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) week 0, 4, 9, 14 and 20
- Secondary Outcome Measures
Name Time Method 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 ECG readings 20 weeks 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 changes from baseline in laboratory measurements 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
Trial Locations
- Locations (76)
Pivotal Research Center
🇺🇸Peoria, Arizona, United States
Xenoscience
🇺🇸Phoenix, Arizona, United States
Boehringer Ingelheim Investigational Site
🇨🇦Greenfield Park, Quebec, Canada
California Clinical Trials Medical Group
🇺🇸Culver City, California, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Care@ Granada Hills Community Hospital
🇺🇸Granada Hills, California, United States
Optimum Health Services
🇺🇸Oceanside, California, United States
Southwest Institute for Clinical Research
🇺🇸Rancho Mirage, California, United States
Health Quest Clinical Trials
🇺🇸San Diego, California, United States
Institute on Aging Research Center
🇺🇸San Francisco, California, United States
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