Study of Memantine to Treat Huntington's Disease

NCT00652457 | Completed Phase 4 Results DMC

• 1 other identifier: MEM-HD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Huntington's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neuropsychiatric Inventory (NPI)

  Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment

Study Arms (2)

Memantine

EXPERIMENTAL

Memantine 10 mg BID for three months

Drug: Memantine

Placebo

PLACEBO COMPARATOR

Placebo 10 mg BID for three months

Drug: Memantine

Interventions

Memantine DRUG

10 mg BID x 3 months

Also known as: Namenda

Memantine; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Jody Corey-Bloom, MD, PhD: lead
• Forest Laboratories: collaborator

Study Sites (3)

University of California, San Diego

La Jolla, California, 92037, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Huntington Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Due to the age of this study (2003), the data is no longer accessible. We have been moved a number of times in 17 years and that data has been lost. The only information we have was provided here in the Results section.

Results Point of Contact

• Title: Jody Corey-Bloom, MD, PhD
• Organization: University of California, San Diego

jcoreybloom@ucsd.edu

858-249-0574

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 3, 2008
• Study Start: November 23, 2004
• Primary Completion: October 28, 2009
• Study Completion: October 28, 2009
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12

Locations

US (3)