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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00153010 |
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.
Condition | Intervention | Phase |
Alzheimer Disease |
Drug: NS 2330 (Tesofensine) |
Phase II |
Genetics Home Reference related topics: | Alzheimer disease |
MedlinePlus related topics: | Alzheimer's Disease Dementia |
ChemIDplus related topics: | Tesofensine NS 2330 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
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 |
Estimated Enrollment: | 420 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | September 2005 |
Ages Eligible for Study: | 40 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
Patients may be included in this study if they meet all of the following criteria:
EXCLUSION CRITERIA
Patients must be excluded from this study if they meet any of the following criteria:
History or diagnosis of symptomatic and/or unstable/uncontrolled:
Use of any drug within 14 days prior to randomization unless:
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Show 87 Study Locations |
Boehringer Ingelheim Pharmaceuticals |
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
Study ID Numbers: | 1198.52 |
First Received: | September 9, 2005 |
Last Updated: | January 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00153010 |
Health Authority: | United States: Food and Drug Administration |
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