Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT01023867
Status:
COMPLETED
Last Update Posted:
2016-01-06
First Post:
2009-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000093902', 'term': 'Mixed Dementias'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2009-11-30', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)", 'timeFrame': '13 weeks, 26 weeks, 39 weeks, 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Seoul Activities of Daily Living (S-ADL)', 'timeFrame': '13 weeks, 26 weeks, 39 weeks, 52 weeks'}, {'measure': 'Seoul-Instrumental Activities of Daily Living (S-IADL)', 'timeFrame': '13 weeks, 26 weeks, 39 weeks, 52 weeks'}, {'measure': 'Korean Neuropsychiatric Inventory (K-NPI)', 'timeFrame': '13 weeks, 26 weeks, 39 weeks, 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'Mixed Dementia', 'Donepezil', 'Efficacy', 'Adverse Event'], 'conditions': ["Alzheimer's Disease", 'Dementia']}, 'descriptionModule': {'briefSummary': "To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.", 'detailedDescription': "The purposes of this study are:\n\n1. to compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia\n2. to help to clinicians in choosing the best treatment for patients with mixed dementia"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. A diagnosis of probable AD and Mixed Dementia 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': 'NCT01023867', 'briefTitle': "Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia", 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': "Comparative Assessment of Clinical Efficacy of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia", 'orgStudyIdInfo': {'id': '2007-03-039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Alzheimer's disease group", 'description': "Patients with Alzheimer's disease treated donepezil", 'interventionNames': ['Drug: donepezil']}, {'type': 'EXPERIMENTAL', 'label': 'Mixed Dementia group', 'description': 'Patients with Mixed Dementia treated donepezil', 'interventionNames': ['Drug: donepezil']}], 'interventions': [{'name': 'donepezil', 'type': 'DRUG', 'otherNames': ['donepezil-aricept'], 'description': 'from 5mg to 10mg, once a day, 12 months', 'armGroupLabels': ["Alzheimer's disease group", 'Mixed Dementia 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': 'Eisai Korea Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Doh Kwan Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}