The purpose of this study is to assess the safety and efficacy of Dimebon in combination with donepezil (Aricept) in the treatment of Alzheimer's disease...
Date First Received: June 23, 2008
Last Updated: June 10, 2009
Verified by: Medivation, Inc., June 2009
Clinical Trial Phase: Phase 1 | Start Date: May 2008
Overall Status: Active, not recruiting
Estimated Enrollment: 21
Brief Summary
Official Title: “An Open-Label Extension Study of Combination Therapy With Dimebon and Donepezil in Patients With Alzheimer's Disease”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to assess the safety and efficacy of Dimebon in combination with donepezil (Aricept) in the treatment of Alzheimer's disease.
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Study Primary Completion Date: November 2008
Intervention(s) in this Clinical Trial
- Drug: dimebon
- Dimebon orally three times daily
Outcome Measures for this Clinical Trial
Primary Measures
- To assess the safety of Dimebon in combination with donepezil (Aricept)
- Time Frame: week 12
Safety Issue?: Yes
- Time Frame: week 12
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Alzheimer's disease
- On donepezil (Aricept)
- Caregiver who cares for the patient at least 5 days per week
Exclusion Criteria:
- Unstable medical illnesses or significant hepatic or renal disease
- Other primary psychiatric or neurological disorders
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Medivation, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00704782
Study ID Number: DIM13
ClinicalTrials.gov Identifier: NCT00704782
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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