Huntington's Disease
Conditions
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.
Interventions
DRUGMemantine
10 mg BID x 3 months
Sponsors
Forest Laboratories
Jody Corey-Bloom, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Sixty-five participants were screened for eligibility; 6 individuals failed screening by not meeting inclusion criteria forthe study; 9 declined to participate. Fifty participants were then randomized.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Total of all reporting groups due to age of study. Data was not analyzed per arm. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 47.3 years |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 27 |
| other Total, other adverse events | 4 / 23 | 1 / 27 |
| serious Total, serious adverse events | 0 / 23 | 0 / 27 |
Outcome results
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.
Time frame: Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment
Population: 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.
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.
Time frame: Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment
Population: 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.