Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil
NCT00829816
ABOUT THIS STUDY
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1-800-718-1021
- 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
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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 |
| ||
Study Arms ICMJE |
| ||
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:
| ||
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 | 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 |