Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-05 @ 5:28 PM
Study NCT ID:
NCT00165750
Status:
TERMINATED
Last Update Posted:
2013-11-20
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077265', 'term': 'Donepezil'}], 'ancestors': [{'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': 'Lack of patients to enroll.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-19', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI, ADAS-cog', 'timeFrame': '0, 12, 24 weeks'}], 'secondaryOutcomes': [{'measure': 'ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus', 'timeFrame': '0, 12, 24 weeks'}]}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "This study investigate the relationship between regional brain volume measured by MRI and donepezil treatment response in patients with Alzheimer's Disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Over 60 years old.\n2. Probable or possible Alzheimer's Disease according to the DSM-IV and NINCDS-ADRDA.\n3. MMSE score of 10\\~24, CDR of 1\\~2.\n4. Patients didn't take acetylcholinesterase inhibitors 4 weeks before screening.\n5. Permitted drugs: antipsychiatric drug for BPSD, antidepression drug, tranquilizer, treatment drug for physical disease for example hypertension.\n\nExclusion criteria:\n\n1. Uncontrolled by donepezil because of adverse events.\n2. No longer continuing treatment of donepezil for refuse, drug-drug interaction etc.\n3. If they have taken concomitant medication which were not allowed."}, 'identificationModule': {'nctId': 'NCT00165750', 'briefTitle': 'Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients', 'orgStudyIdInfo': {'id': 'AS-019 (EKI-5-003)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: DONEPEZIL HYDROCHLORIDE']}], 'interventions': [{'name': 'DONEPEZIL HYDROCHLORIDE', 'type': 'DRUG', 'otherNames': ['Aricept'], 'description': 'One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gwangju', 'state': 'Gwangju', 'country': 'South Korea', 'facility': 'Cheonnam University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}], 'overallOfficials': [{'name': 'Jihee Mun', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eisai Korea Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Korea Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}