Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-29 @ 11:57 PM
Study NCT ID:
NCT01029132
Status:
COMPLETED
Last Update Posted:
2016-01-06
First Post:
2009-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristics of Treatment Responders to Galantamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005702', 'term': 'Galantamine'}], 'ancestors': [{'id': 'D047151', 'term': 'Amaryllidaceae Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2009-12-06', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K)", 'timeFrame': 'baseline, 4w, 13w, 26w, 39w, 52w'}], 'secondaryOutcomes': [{'measure': 'Seoul-Activities of Daily Living (S-ADL) Seoul-Instrumental Activities of Daily Living (S-IADL) Korean version Neuropsychiatric Inventory (K-NPI)', 'timeFrame': 'baseline, 4w, 13w, 26w, 39w, 52w'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'Galantamine', 'Treatment response', 'Efficacy', 'Adverse Event'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'To investigate the characteristics of treatment responders to galantamine.', 'detailedDescription': 'The purposes of this study are:\n\n1. to investigate the characteristics of treatment responders to galantamine by examining the clinical response of galantamine in patients with mild to moderate AD for 52 weeks.\n2. to examine the specific cognitive sub-domains that are more sensitive to galantamine administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA\n2. Korean version Mini-Mental State Examination scores between 10 and 26\n3. History of cognitive decline that had been gradual in onset and progressive over at least 6 months\n4. A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.\n\nExclusion Criteria:\n\n1. they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)\n2. Psychiatric disorder or severe behavioral disturbances that required psychotropic medications\n3. Cerebral injuries induced by trauma, hypoxia, and/or ischemia\n4. Clinically active cerebrovascular disease; History of seizure disorder\n5. Other physical conditions that required acute treatment."}, 'identificationModule': {'nctId': 'NCT01029132', 'briefTitle': 'Characteristics of Treatment Responders to Galantamine', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': "Characteristics of Treatment Responders to Galantamine Administration in the Patients With Alzheimer's Disease", 'orgStudyIdInfo': {'id': '2007-04-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'non-responder group', 'description': 'patients who did not maintained or improved cognitive function', 'interventionNames': ['Drug: galantamine']}, {'type': 'EXPERIMENTAL', 'label': 'responder group', 'description': 'patients who maintained or improved cognitive function', 'interventionNames': ['Drug: galantamine']}], 'interventions': [{'name': 'galantamine', 'type': 'DRUG', 'otherNames': ['galantamine-reminyl'], 'description': "8 mg/day (4 mg bid) during the first 4 weeks, up to a maximum of 24 mg/day (12 mg bid) at intervals of 4 weeks, from 16 to 24 mg/day based on the patient's tolerability", 'armGroupLabels': ['non-responder group', 'responder group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Doh Kwan Kim, PhD, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Korea, Ltd., Korea', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Doh Kwan Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}