Status:
COMPLETED
Study of Memantine to Treat Huntington's Disease
Lead Sponsor:
Jody Corey-Bloom, MD, PhD
Collaborating Sponsors:
Forest Laboratories
Conditions:
Huntington's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 beh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 23 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00652457
Start Date
November 23 2004
End Date
October 28 2009
Last Update
January 5 2021
Active Locations (3)
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1
University of California, San Diego
La Jolla, California, United States, 92037
2
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
3
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287