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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memantine | Experimental | Memantine 10 mg BID for three months |
|
| Placebo | Placebo Comparator | Placebo 10 mg BID for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | 10 mg BID x 3 months |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037 | United States | ||
| University of Kansas Medical Center |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Memantine, Then Memantine | Participants first received 10 mg Memantine twice a day for 3 months. No washout. Participants continued on 10 mg Memantine twice a day for another 3 months. |
| FG001 | Placebo, Then Memantine | Participants first received Placebo twice a day for 3 months. No washout. Participants then received 10 mg Memantine twice a day for 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Total of all reporting groups due to age of study. Data was not analyzed per arm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment |
|
6 months
Due to the age of this study (2003), the data regarding individual arms is no longer accessible. We have been moved a number of times in 17 years and that data has been lost.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Memantine, Then Memantine | Participants first received 10 mg Memantine twice a day for 3 months. No washout. Participants continued on 10 mg Memantine twice a day for another 3 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jody Corey-Bloom, MD, PhD | University of California, San Diego | 858-249-0574 | jcoreybloom@ucsd.edu |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants first received 10 mg Memantine twice a day for 3 months. No washout. Participants continued on 10 mg Memantine twice a day for another 3 months. |
| OG001 | Placebo, Then Memantine | Participants first received Placebo twice a day for 3 months. No washout. Participants then received 10 mg Memantine twice a day for 3 months. |
|
| 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. | 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. | Posted | Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 4 |
| 23 |
| EG001 | Placebo, Then Memantine | Participants first received Placebo twice a day for 3 months. No washout. Participants then received 10 mg Memantine twice a day for 3 months. | 0 | 27 | 0 | 27 | 1 | 27 |
| Diarrhea | Gastrointestinal disorders |
|
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| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |