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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00810147 |
The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with mild to moderate Alzheimer's disease over a treatment period of 12-weeks and the course of any potential effects during a 12-week wash-out period
Condition | Intervention | Phase |
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Alzheimer's Disease |
Drug: BMS-708163 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
Official Title: | Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients With Mild to Moderate Alzheimer's Disease |
Estimated Enrollment: | 200 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Active Comparator |
Drug: BMS-708163
Capsules, Oral, 25 mg, once daily, 12 weeks
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A2: Active Comparator |
Drug: BMS-708163
Capsules, Oral, 50 mg, once daily, 12 weeks
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A3: Active Comparator |
Drug: BMS-708163
Capsules, Oral, 100 mg, once daily, 12 weeks
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A4: Active Comparator |
Drug: BMS-708163
Capsules, Oral, 125 mg, once daily, 12 weeks
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A5: Placebo Comparator |
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 12 weeks
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Ages Eligible for Study: | 50 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CN156-013, EUDRACT: 2008-005929-11 |
Study First Received: | December 16, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00810147 |
Health Authority: | United States: Food and Drug Administration; Denmark: Danish Medicines Agency; Sweden: Medical Product Agency; Finland: National Agency for Medicines |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |