Study of Memantine to Treat Huntington's Disease

Phase 4

Completed

• Conditions: Huntington's Disease
• Interventions: Drug: Memantine

• Registration Number: NCT00652457
• Lead Sponsor: Jody Corey-Bloom, MD, PhD

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-11-23
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-03
• Primary Completion: 2009-10-28
• Study Completion: 2009-10-28
• Results First Submitted: 2020-10-08
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-08
• Last Update Submitted: 2020-12-08
• Results First Posted: 2021-01-05
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Memantine	Placebo 10 mg BID for three months
Memantine	Memantine	Memantine 10 mg BID for three months

Primary Outcome Measures

Name	Time	Method
Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall)	Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment	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.

Secondary Outcome Measures

Name	Time	Method
Neuropsychiatric Inventory (NPI)	Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment	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.

Trial Locations

Locations (3)

University of California, San Diego; 🇺🇸 La Jolla, California, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States