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Study of Memantine to Treat Huntington's Disease

Primary Purpose

Huntington's Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Memantine
Sponsored by
Jody Corey-Bloom, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Diego
  • University of Kansas Medical Center
  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Memantine

Placebo

Arm Description

Memantine 10 mg BID for three months

Placebo 10 mg BID for three months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 31, 2008
Last Updated
December 8, 2020
Sponsor
Jody Corey-Bloom, MD, PhD
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00652457
Brief Title
Study of Memantine to Treat Huntington's Disease
Official Title
A Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington's Disease"
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 23, 2004 (Actual)
Primary Completion Date
October 28, 2009 (Actual)
Study Completion Date
October 28, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jody Corey-Bloom, MD, PhD
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memantine
Arm Type
Experimental
Arm Description
Memantine 10 mg BID for three months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 10 mg BID for three months
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Namenda
Intervention Description
10 mg BID x 3 months
Primary Outcome Measure Information:
Title
Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall)
Description
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.
Time Frame
Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment
Secondary Outcome Measure Information:
Title
Neuropsychiatric Inventory (NPI)
Description
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.
Time Frame
Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Study of Memantine to Treat Huntington's Disease

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