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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on October 19, 2014