Trial record 1 of 1 for:
NCT00829816
Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil
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ClinicalTrials.gov Identifier: NCT00829816 |
Recruitment Status :
Completed
First Posted : January 27, 2009
Last Update Posted : November 10, 2015
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Sponsor:
Medivation, Inc.
Information provided by (Responsible Party):
Medivation, Inc.
Tracking Information | |||
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First Submitted Date ICMJE | January 12, 2009 | ||
First Posted Date ICMJE | January 27, 2009 | ||
Last Update Posted Date | November 10, 2015 | ||
Study Start Date ICMJE | December 2008 | ||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
To assess the safety and tolerability of orally administered dimebon in patients with Alzheimer's disease (AD) on a stable dose and regimen of memantine, or memantine plus donepezil. [ Time Frame: up to 28 days ] Treatment discontinuation due to adverse events, the frequency and severity of adverse events, and clinically significant changes in safety assessments (including physical examination findings, vital signs, laboratory values, and ECGs) in the dimebon group will be compared to those reported in the placebo group.
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Original Primary Outcome Measures ICMJE |
To assess the safety and tolerability of orally administered Dimebon in patients with Alzheimer's disease on a stable dose and regimen of memantine, or memantine plus donepezil. | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
To assess the steady-state pharmacokinetics (PK) of orally-administered dimebon in patients with AD on a stable dose and regimen of memantine, or memantine plus donepezil. [ Time Frame: up to 28 days ] The following key parameters will be used to assess the steady-state PK of dimebon: maximum plasma concentration (Cmax), time to maximum plasma concentration (tmax), Ctrough, area under the curve (AUC), and peak-to-trough ratio.
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Original Secondary Outcome Measures ICMJE |
To assess the steady-state pharmacokinetics (PK) of orally-administered dimebon in patients with AD on a stable dose and regimen of memantine, or memantine plus donepezil. | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
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 |
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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. |
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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 |