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Sponsors and Collaborators: |
Pfizer Medivation, Inc. |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00838110 |
This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.
Condition | Intervention | Phase |
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Alzheimer's Disease |
Drug: Dimebon Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study |
Official Title: | A Phase 3, Multi-Center, Randomized, Double-Blind Placebo-Controlled Study To Evaluate The Safety And Tolerability Of Dimebon (PF-01913539) For Up To 26-Weeks In Patients With Mild To Moderate Alzheimer's Disease |
Estimated Enrollment: | 750 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Dimebon 20 mg TID (Cohort 1): Experimental |
Drug: Dimebon
10 mg TID for week 1 followed by 20 mg TID through Week 26
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Placebo TID (Cohort 1): Placebo Comparator |
Drug: Placebo
10 mg TID for week 1 followed by 20 mg TID through Week 26
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Dimebon 20 mg TID (Cohort 2): Experimental |
Drug: Dimebon
10 mg TID for week 1 followed by 20 mg TID through Week 12
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Placebo TID (Cohort 2): Placebo Comparator |
Drug: Placebo
20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | B1451027 |
Study First Received: | February 5, 2009 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00838110 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Alzheimer's Disease, Dimebon, Safety, Tolerability |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |