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.
- Alzheimer's disease
- On donepezil (Aricept)
- Caregiver who cares for the patient at least 5 days per week
- Unstable medical illnesses or significant hepatic or renal disease
- Other primary psychiatric or neurological disorders
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease | ||
| Official Title ICMJE | An Open-Label Extension Study of Combination Therapy With Dimebon and Donepezil in Patients With Alzheimer's Disease | ||
| Brief Summary | 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. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 2 | ||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||
| Condition ICMJE | Alzheimer's Disease | ||
| Intervention ICMJE | Drug: dimebon | ||
| Study Arms ICMJE | Experimental: Dimebon 20 mg by mouth 3 times a day Intervention: Drug: dimebon | ||
| Publications * | Not Provided | ||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Terminated | ||
| Actual Enrollment ICMJE | 50 | ||
| Original Estimated Enrollment ICMJE | 21 | ||
| Actual Study Completion Date ICMJE | August 2010 | ||
| Actual Primary Completion Date | August 2010 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00704782 | ||
| Other Study ID Numbers ICMJE | DIM13 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Medivation, Inc. | ||
| Study Sponsor ICMJE | Medivation, Inc. | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Medivation, Inc. | ||
| Verification Date | November 2015 | ||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
