Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-25 @ 1:41 PM
Study NCT ID:
NCT00652457
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2008-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Memantine to Treat Huntington's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008559', 'term': 'Memantine'}], 'ancestors': [{'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jcoreybloom@ucsd.edu', 'phone': '858-249-0574', 'title': 'Jody Corey-Bloom, MD, PhD', 'organization': 'University of California, San Diego'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Memantine, Then Memantine', 'description': '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.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 4, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo, Then Memantine', 'description': 'Participants first received Placebo twice a day for 3 months. No washout. Participants then received 10 mg Memantine twice a day for 3 months.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 1, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantine, Then Memantine', 'description': '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.'}, {'id': 'OG001', 'title': 'Placebo, Then Memantine', 'description': 'Participants first received Placebo twice a day for 3 months. No washout. Participants then received 10 mg Memantine twice a day for 3 months.'}], 'timeFrame': 'Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment', '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.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Neuropsychiatric Inventory (NPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantine, Then Memantine', 'description': '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.'}, {'id': 'OG001', 'title': 'Placebo, Then Memantine', 'description': 'Participants first received Placebo twice a day for 3 months. No washout. Participants then received 10 mg Memantine twice a day for 3 months.'}], 'timeFrame': 'Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment', 'description': 'The Neuropsychiatric Inventory (NPI) assesses the frequency and severity of 12 common behavioral symptoms in dementia.\n\nThe 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.\n\nThe change between 2 or more time points is being reported.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Memantine, Then Memantine', 'description': '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.'}, {'id': 'FG001', 'title': 'Placebo, Then Memantine', 'description': 'Participants first received Placebo twice a day for 3 months. No washout. Participants then received 10 mg Memantine twice a day for 3 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Total of all reporting groups due to age of study. Data was not analyzed per arm.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': 'NA', 'comment': 'Due to the age of this study (2003), the only age-related results available is the mean age of all participants. The standard deviation was not calculated and the data is no longer accessible.', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2009-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-08', 'studyFirstSubmitDate': '2008-03-31', 'resultsFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2008-03-31', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-08', 'studyFirstPostDateStruct': {'date': '2008-04-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall)', 'timeFrame': 'Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment', '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.'}], 'secondaryOutcomes': [{'measure': 'Neuropsychiatric Inventory (NPI)', 'timeFrame': 'Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment', 'description': 'The Neuropsychiatric Inventory (NPI) assesses the frequency and severity of 12 common behavioral symptoms in dementia.\n\nThe 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.\n\nThe change between 2 or more time points is being reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Huntington's Disease"]}, 'descriptionModule': {'briefSummary': "To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD).", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men or women aged 18 or older.\n* Diagnosis of HD with current complaints of memory or concentration difficulties.\n* Dementia Rating Scale score of \\<129, to ensure that patients have sufficient cognitive impairment.\n* Adequate visual and auditory acuity to allow neuropsychological testing.\n* Good general health with no additional diseases expected to interfere with the study.\n* Patient is not institutionalized.\n* Sufficient English skills to complete all testing without assistance of an English language interpreter.\n* 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.\n\nExclusion Criteria:\n\n* 1\\. Any significant neurologic disease other than HD.\n* Severe psychotic features or other severe psychiatric problems within the last three months which could lead to difficulty complying with the protocol.\n* History of alcohol or substance abuse within the past two years (DSM IV criteria).\n* Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.\n* History of MI in the past year or head trauma with loss of consciousness greater than 20 minutes.\n* Insulin-requiring diabetes.\n* Use of any FDA approved cognitive enhancing prescription medications or investigational drugs within 30 days.\n* Use of ginkgo biloba or DHEA within four weeks prior to baseline.\n* Use of narcotic analgesics within 4 weeks prior to baseline.\n* Patients who, in the investigator's opinion, would not comply with study procedures."}, 'identificationModule': {'nctId': 'NCT00652457', 'briefTitle': "Study of Memantine to Treat Huntington's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'A Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington\'s Disease"', 'orgStudyIdInfo': {'id': 'MEM-HD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Memantine', 'description': 'Memantine 10 mg BID for three months', 'interventionNames': ['Drug: Memantine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo 10 mg BID for three months', 'interventionNames': ['Drug: Memantine']}], 'interventions': [{'name': 'Memantine', 'type': 'DRUG', 'otherNames': ['Namenda'], 'description': '10 mg BID x 3 months', 'armGroupLabels': ['Memantine', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jody Corey-Bloom, MD, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Forest Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jody Corey-Bloom, MD, PhD', 'investigatorAffiliation': 'University of California, San Diego'}}}}