The purpose of this study is to evaluate the safety and tolerability of dimebon given to Alzheimer's disease patients currently on a stable dose and regimen of memantine or memantine plus donepezil.
- Alzheimer's disease
- On Memantine
- Caregiver who is willing to accompany the patient to all clinic visits
- 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 | Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil | ||
| Official Title ICMJE | A Multi-Center Phase 1 Study of the Safety and Tolerability of Dimebon in Alzheimer's Disease Patients on Memantine (Cohort 1) and Memantine Plus Donepezil (Cohort 2) | ||
| Brief Summary | The purpose of this study is to evaluate the safety and tolerability of dimebon given to Alzheimer's disease patients currently on a stable dose and regimen of memantine or memantine plus donepezil. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 1 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||
| Condition ICMJE | Alzheimer's Disease | ||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| 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 | Completed | ||
| Actual Enrollment ICMJE | 46 | ||
| Original Estimated Enrollment ICMJE | 44 | ||
| Actual Study Completion Date ICMJE | August 2010 | ||
| Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 | NCT00829816 | ||
| Other Study ID Numbers ICMJE | DIM17 | ||
| Has Data Monitoring Committee | No | ||
| 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
