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
Recruitment status was Recruiting
Sponsor:
University of California, San Diego
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
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Purpose
To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD).
| Condition | Intervention | Phase |
|---|---|---|
|
Huntington's Disease |
Drug: Memantine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington's Disease" |
Resource links provided by NLM:
Genetics Home Reference related topics:
chorea-acanthocytosis
Huntington disease
McLeod neuroacanthocytosis syndrome
MedlinePlus related topics:
Huntington's Disease
U.S. FDA Resources
Further study details as provided by University of California, San Diego:
Primary Outcome Measures:
- sensitive neuropsychological battery [ Time Frame: three months and six months of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- behavioral and functional measures at three and six months of treatment [ Time Frame: three and six months of treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Memantine 10 mg BID for three months
|
Drug: Memantine
10 mg BID x 3 months
Other Name: Namenda
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652457
Contacts
| Contact: Jody Corey-Bloom, MD, PhD | 858-642-3470 | jcoreybl@vapop.ucsd.edu |
| Contact: Jody Goldstein, BA | 858-622-5854 | jlgoldstein@ucsd.edu |
Locations
| United States, California | |
| University of California, San Diego | Recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: Jody Corey-Bloom, MD, PhD 858-642-3470 jcoreybl@vapop.ucsd.edu | |
| Contact: Jody Goldstein, BA 858-622-5854 jlgoldstein@ucsd.edu | |
| Principal Investigator: Jody Corey-Bloom, MD, PhD | |
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Richard Dubinsky, MD, MPH rdubinsky@safetyresearch.com | |
| Contact: Janice Broyles-Gorman jbroyles-gorman@kumc.edu | |
| Principal Investigator: Richard Dubinsky, MD, MPH | |
| United States, Maryland | |
| Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Adam Roseblatt, MD 410-955-2398 arosenb3@jhmi.edu | |
| Contact: Nadine Yoritomo nyorito1@jhmi.edu | |
| Principal Investigator: Adam Rosenblatt, MD | |
Sponsors and Collaborators
University of California, San Diego
Forest Laboratories
More Information
No publications provided
| Responsible Party: | Jody Corey-Bloom, MD, PhD, Department of Neurosciences, University of California San Diego |
| ClinicalTrials.gov Identifier: | NCT00652457 History of Changes |
| Other Study ID Numbers: | MEM-HD |
| Study First Received: | March 31, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Food and Drug Administration (IND exemption) |
Additional relevant MeSH terms:
|
Huntington Disease Memantine Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Dementia Chorea Dyskinesias Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Cognition Disorders |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013