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Study of Memantine to Treat Huntington's Disease
This study is currently recruiting participants.
Verified by University of California, San Diego, March 2008
First Received: March 31, 2008   No Changes Posted
Sponsor: University of California, San Diego
Collaborator: Forest Laboratories
Information provided by: University of California, San Diego
ClinicalTrials.gov Identifier: NCT00652457
  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 IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
Official Title: A Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington's Disease"

Resource links provided by NLM:


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
1: Experimental
Memantine 10 mg BID for three months
Drug: Memantine
10 mg BID x 3 months

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: Department of Neurosciences, University of California San Diego ( Jody Corey-Bloom, MD, PhD )
Study ID Numbers: MEM-HD
Study First Received: March 31, 2008
Last Updated: March 31, 2008
ClinicalTrials.gov Identifier: NCT00652457     History of Changes
Health Authority: United States: Food and Drug Administration (IND exemption)

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Basal Ganglia Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents
Neurodegenerative Diseases
Brain Diseases
Heredodegenerative Disorders, Nervous System
Movement Disorders
Mental Disorders
Therapeutic Uses
Memantine
Dementia
Excitatory Amino Acid Antagonists
Nervous System Diseases
Central Nervous System Diseases
Dyskinesias
Cognition Disorders
Pharmacologic Actions
Chorea
Delirium, Dementia, Amnestic, Cognitive Disorders
Genetic Diseases, Inborn
Dopamine Agents
Central Nervous System Agents
Huntington Disease

ClinicalTrials.gov processed this record on November 27, 2009