Study of Memantine to Treat Huntington's Disease

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

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

Study Overview

• Status: Completed
• Conditions: Huntington's Disease
• Intervention / Treatment: Drug: Memantine

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California, San Diego
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Memantine; Memantine 10 mg BID for three months	Drug: Memantine; 10 mg BID x 3 months; Other Names: Namenda
Placebo Comparator: Placebo; Placebo 10 mg BID for three months	Drug: Memantine; 10 mg BID x 3 months; Other Names: Namenda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jody Corey-Bloom, MD, PhD
• Collaborators: Forest Laboratories

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2004
• Primary Completion (Actual): October 28, 2009
• Study Completion (Actual): October 28, 2009

Study Registration Dates

• First Submitted: March 31, 2008
• First Submitted That Met QC Criteria: March 31, 2008
• First Posted (Estimate): April 3, 2008

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Heredodegenerative Disorders, Nervous System; Dementia; Cognition Disorders; Chorea; Huntington Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Memantine
• Other Study ID Numbers: MEM-HD