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Study of Memantine to Treat Huntington's Disease

This study is currently recruiting participants.
Study NCT00652457.   Last updated on March 31, 2008.   Information provided by University of California, San Diego

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Descriptive Information Fields
Brief Title  Study of Memantine to Treat Huntington's Disease
Official Title  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).

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.

Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
Primary Outcome Measure  sensitive neuropsychological battery [ Time Frame: three months and six months of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measure  behavioral and functional measures at three and six months of treatment [ Time Frame: three and six months of treatment ] [ Designated as safety issue: No ]
Condition  Huntington's Disease
Intervention  Drug: Memantine
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  60
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Men or women aged 18 or older.
  • Diagnosis of HD with current complaints of memory or concentration difficulties.
  • Dementia Rating Scale score of <129, to ensure that patients have sufficient cognitive impairment.
  • Adequate visual and auditory acuity to allow neuropsychological testing.
  • Good general health with no additional diseases expected to interfere with the study.
  • Patient is not institutionalized.
  • Sufficient English skills to complete all testing without assistance of an English language interpreter.
  • Availability of a responsible caregiver who agrees to supervise administration of study drug, monitor the patient's compliance and adverse events, and accompany the patient to all clinic visits.

Exclusion Criteria:

  • 1. Any significant neurologic disease other than HD.
  • Severe psychotic features or other severe psychiatric problems within the last three months which could lead to difficulty complying with the protocol.
  • History of alcohol or substance abuse within the past two years (DSM IV criteria).
  • Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
  • History of MI in the past year or head trauma with loss of consciousness greater than 20 minutes.
  • Insulin-requiring diabetes.
  • Use of any FDA approved cognitive enhancing prescription medications or investigational drugs within 30 days.
  • Use of ginkgo biloba or DHEA within four weeks prior to baseline.
  • Use of narcotic analgesics within 4 weeks prior to baseline.
  • Patients who, in the investigator's opinion, would not comply with study procedures.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Jody Corey-Bloom, MD, PhD     858-642-3470     jcoreybl@vapop.ucsd.edu    
Contact: Jody Goldstein, BA     858-622-5854     jlgoldstein@ucsd.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00652457
Organization ID MEM-HD
Secondary IDs ††
Study Sponsor  University of California, San Diego
Collaborators †† Forest Laboratories
Investigators 
Information Provided By University of California, San Diego
Verification Date March 2008
First Received Date  March 31, 2008
Last Updated Date March 31, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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