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
Information provided by:
University of California, San Diego
First received: March 31, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD).
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington's Disease"
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 ]
Memantine 10 mg BID for three months
10 mg BID x 3 months
Other Name: Namenda
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00652457
|University of California, San Diego
|La Jolla, California, United States, 92037 |
|Contact: Jody Corey-Bloom, MD, PhD 858-642-3470 firstname.lastname@example.org |
|Contact: Jody Goldstein, BA 858-622-5854 email@example.com |
|Principal Investigator: Jody Corey-Bloom, MD, PhD |
|University of Kansas Medical Center
|Kansas City, Kansas, United States, 66160 |
|Contact: Richard Dubinsky, MD, MPH firstname.lastname@example.org |
|Contact: Janice Broyles-Gorman email@example.com |
|Principal Investigator: Richard Dubinsky, MD, MPH |
|Johns Hopkins Hospital
|Baltimore, Maryland, United States, 21287 |
|Contact: Adam Roseblatt, MD 410-955-2398 firstname.lastname@example.org |
|Contact: Nadine Yoritomo email@example.com |
|Principal Investigator: Adam Rosenblatt, MD |
University of California, San Diego
No publications provided
||Jody Corey-Bloom, MD, PhD, Department of Neurosciences, University of California San Diego
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 31, 2008
||March 31, 2008
||United States: Food and Drug Administration (IND exemption)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Delirium, Dementia, Amnestic, Cognitive Disorders
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Central Nervous System Agents