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| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | March 31, 2008 | ||||||||
| Last Updated Date | March 31, 2008 | ||||||||
| Start Date ICMJE | |||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
sensitive neuropsychological battery [ Time Frame: three months and six months of treatment ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
behavioral and functional measures at three and six months of treatment [ Time Frame: three and six months of treatment ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Memantine to Treat Huntington's Disease | ||||||||
| Official Title ICMJE | A Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington's Disease" | ||||||||
| Brief Summary | To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD). |
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| Detailed Description | Results of several published clinical trials suggest that memantine has a beneficial effect in dementing conditions, such as Alzheimer's disease; however, the effects of memantine on cognitive and behavioral function in HD are unknown. Our hypotheses are that HD patients who are administered memantine will show improved performance on psychometric tests of memory and executive functions in addition to behavior and that patients treated with memantine will show more improvement after six months than after three months of treatment. |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Huntington's Disease | ||||||||
| Intervention ICMJE | Drug: Memantine | ||||||||
| Study Arms / Comparison Groups | Experimental: Memantine 10 mg BID for three months | ||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 60 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00652457 | ||||||||
| Responsible Party | Jody Corey-Bloom, MD, PhD, Department of Neurosciences, University of California San Diego | ||||||||
| Study ID Numbers ICMJE | MEM-HD | ||||||||
| Study Sponsor ICMJE | University of California, San Diego | ||||||||
| Collaborators ICMJE | Forest Laboratories | ||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | University of California, San Diego | ||||||||
| Verification Date | March 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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