Study of Memantine to Treat Huntington's Disease
Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Huntington's Disease
Intervention: Memantine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of California, San Diego Overall contact:
Jody Corey-Bloom, MD, PhD, Phone: 858-642-3470, Email: jcoreybl@vapop.ucsd.edu
Summary
To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in
patients with Huntington's disease (HD).
Clinical Details
Official title: A Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington's Disease"
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: sensitive neuropsychological battery
Secondary outcome: behavioral and functional measures at three and six months of treatment
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Jody Corey-Bloom, MD, PhD, Phone: 858-642-3470, Email: jcoreybl@vapop.ucsd.edu
University of California, San Diego, La Jolla, California 92037, United States; Recruiting
Jody Corey-Bloom, MD, PhD, Phone: 858-642-3470, Email: jcoreybl@vapop.ucsd.edu
Jody Goldstein, BA, Phone: 858-622-5854, Email: jlgoldstein@ucsd.edu
Jody Corey-Bloom, MD, PhD, Principal Investigator
University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting
Richard Dubinsky, MD, MPH, Email: rdubinsky@safetyresearch.com
Janice Broyles-Gorman, Email: jbroyles-gorman@kumc.edu
Richard Dubinsky, MD, MPH, Principal Investigator
Johns Hopkins Hospital, Baltimore, Maryland 21287, United States; Recruiting
Adam Roseblatt, MD, Phone: 410-955-2398, Email: arosenb3@jhmi.edu
Nadine Yoritomo, Email: nyorito1@jhmi.edu
Adam Rosenblatt, MD, Principal Investigator
Additional Information
Last updated: March 31, 2008
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