Study of Memantine to Treat Huntington's Disease

Huntington's Disease Clinical Trial

Official title:

A Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington's Disease"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652457
• Other study ID #: MEM-HD
• Status: Completed
• Phase: Phase 4
• Start date: November 23, 2004
• Est. completion date: October 28, 2009

Study information

• Verified date: December 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 28, 2009
• Est. primary completion date: October 28, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

Intervention

Drug:
• Memantine
10 mg BID x 3 months

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Jody Corey-Bloom, MD, PhD	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall)	The HVLT-R consists of 3 parts. Free recall has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from the respective later time point value. Imputation methods were used to determine values for all alive patients missing the post-baseline assessments. This tool is being used to measure cognitive function, specifically memory.	Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment
Secondary	Neuropsychiatric Inventory (NPI)	The Neuropsychiatric Inventory (NPI) assesses the frequency and severity of 12 common behavioral symptoms in dementia.; The NPI Score is calculated by multiplying the total reported frequency by the severity score, with a theoretical range of 0-1704: high scores indicating greater frequency by severity.; The change between 2 or more time points is being reported.	Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment