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Study of Memantine to Treat Huntington's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by University of California, San Diego.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00652457
First received: March 31, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted

March 31, 2008
March 31, 2008
Not Provided
Not Provided
sensitive neuropsychological battery [ Time Frame: three months and six months of treatment ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
behavioral and functional measures at three and six months of treatment [ Time Frame: three and six months of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Memantine to Treat Huntington's Disease
A Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington's Disease"

To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Huntington's Disease
Drug: Memantine
10 mg BID x 3 months
Other Name: Namenda
Experimental: 1
Memantine 10 mg BID for three months
Intervention: Drug: Memantine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact: Jody Corey-Bloom, MD, PhD 858-642-3470 jcoreybl@vapop.ucsd.edu
Contact: Jody Goldstein, BA 858-622-5854 jlgoldstein@ucsd.edu
United States
 
NCT00652457
MEM-HD
Yes
Jody Corey-Bloom, MD, PhD, Department of Neurosciences, University of California San Diego
University of California, San Diego
Forest Laboratories
Not Provided
University of California, San Diego
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP