Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-02 @ 5:34 PM
Study NCT ID:
NCT01251718
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2010-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 894}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2010-12-01', 'studyFirstSubmitQcDate': '2010-12-01', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADAS-Jcog (test of cognitive function)', 'timeFrame': '36 month (12 weeks and every 6 months)'}], 'secondaryOutcomes': [{'measure': 'Adverse events/adverse drug reactions', 'timeFrame': '36 months'}]}, 'conditionsModule': {'keywords': ['Donepezil hydrochloride', "Alzheimer's Disease"], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "To investigate the clinical safety and effectiveness of donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Alzheimer's Disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria;\n\nPatients diagnosed as Alzheimer's Disease by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).\n\nPatients diagnosed as mild or moderate Alzheimer's Disease, applicable to Functional Assessment Staging (FAST) score 4 or 5.\n\nExclusion criteria;\n\nPatients who used Aricept within 3 months prior to dosing.\n\nPatients registered this survey before.\n\nPatients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives."}, 'identificationModule': {'nctId': 'NCT01251718', 'briefTitle': "Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': "Post-marketing Surveillance of Donepezil Hydrochloride- Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'ART06T'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Donepezil Hydrochloride', 'interventionNames': ['Drug: donepezil hydrochloride']}], 'interventions': [{'name': 'donepezil hydrochloride', 'type': 'DRUG', 'description': "Initial dose of 3 mg orally once daily. After 1-2 weeks, dosage increased to 5 mg orally once daily. After 4 or more weeks, dosage increased to 10 mg orally once daily for patients with severe dementia of Alzheimer's type. Dose reduced appropriately according to patient's symptoms.", 'armGroupLabels': ['Donepezil Hydrochloride']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anjo', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.95828, 'lon': 137.08054}}, {'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Daisen', 'state': 'Akita', 'country': 'Japan', 'geoPoint': {'lat': 39.44116, 'lon': 140.48961}}, {'city': 'Hirosaki', 'state': 'Aomori', 'country': 'Japan', 'geoPoint': {'lat': 40.59306, 'lon': 140.4725}}, {'city': 'Towada', 'state': 'Aomori', 'country': 'Japan', 'geoPoint': {'lat': 40.62049, 'lon': 141.21067}}, {'city': 'Ichihara', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.51667, 'lon': 140.08333}}, {'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'city': 'Sakura', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.71667, 'lon': 140.23333}}, {'city': 'Iyo', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.75139, 'lon': 132.70139}}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Niihama', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.96047, 'lon': 133.30522}}, {'city': 'Tōon', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.79427, 'lon': 132.89011}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Omuta', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.03333, 'lon': 130.45}}, {'city': 'Ukiha', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.35634, 'lon': 130.74966}}, {'city': 'Iwaki', 'state': 'Fukushima', 'country': 'Japan', 'geoPoint': {'lat': 37.05, 'lon': 140.88333}}, {'city': 'Mizunami', 'state': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.36667, 'lon': 137.25}}, {'city': 'Fujioka', 'state': 'Gunma', 'country': 'Japan', 'geoPoint': {'lat': 36.24624, 'lon': 139.07204}}, {'city': 'Fukuyama', 'state': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.48333, 'lon': 133.36667}}, {'city': 'Kure', 'state': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.23222, 'lon': 132.56658}}, {'city': 'Miyoshi', 'state': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.8, 'lon': 132.85}}, {'city': 'Ōtake', 'state': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.20754, 'lon': 132.22063}}, {'city': 'Hakodate', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 41.77583, 'lon': 140.73667}}, {'city': 'Nayoro', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 44.35056, 'lon': 142.45778}}, {'city': 'Obihiro', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 42.91722, 'lon': 143.20444}}, {'city': 'Otaru', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.18944, 'lon': 141.00222}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sunagawa', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.48639, 'lon': 141.90556}}, {'city': 'Aioi', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.80361, 'lon': 134.46806}}, {'city': 'Akashi', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.65524, 'lon': 135.00687}}, {'city': 'Amagasaki', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'city': 'Himeji', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.81667, 'lon': 134.7}}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Moriya', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 35.93333, 'lon': 140.0}}, {'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Kita', 'state': 'Kagawa-ken', 'country': 'Japan'}, {'city': 'Mitoyo', 'state': 'Kagawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.21052, 'lon': 133.6746}}, {'city': 'Ebina', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.38121, 'lon': 139.39651}}, {'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokosuka', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.28361, 'lon': 139.66722}}, {'city': 'Nankoku', 'state': 'Kochi', 'country': 'Japan', 'geoPoint': {'lat': 33.56943, 'lon': 133.64937}}, {'city': 'Uji', 'state': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 34.89044, 'lon': 135.80325}}, {'city': 'Suzuka', 'state': 'Mie-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.88333, 'lon': 136.58333}}, {'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'city': 'Yokkaichi', 'state': 'Mie-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.96667, 'lon': 136.61667}}, {'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Kitamorokata', 'state': 'Miyazaki', 'country': 'Japan'}, {'city': 'Iida', 'state': 'Nagano', 'country': 'Japan', 'geoPoint': {'lat': 35.51965, 'lon': 137.82074}}, {'city': 'Matsumoto', 'state': 'Nagano', 'country': 'Japan', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Okaya', 'state': 'Nagano', 'country': 'Japan', 'geoPoint': {'lat': 36.05659, 'lon': 138.0451}}, {'city': 'Sasebo', 'state': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 33.16834, 'lon': 129.72502}}, {'city': 'Ikoma', 'state': 'Nara', 'country': 'Japan', 'geoPoint': {'lat': 34.68333, 'lon': 135.7}}, {'city': 'Kashihara', 'state': 'Nara', 'country': 'Japan', 'geoPoint': {'lat': 33.95, 'lon': 135.78333}}, {'city': 'Saiki', 'state': 'Oita Prefecture', 'country': 'Japan', 'geoPoint': {'lat': 32.95, 'lon': 131.9}}, {'city': 'Yufu', 'state': 'Oita Prefecture', 'country': 'Japan', 'geoPoint': {'lat': 33.1956, 'lon': 131.37829}}, {'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'city': 'Izumisano', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.41667, 'lon': 135.31667}}, {'city': 'Kaizuka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.45, 'lon': 135.35}}, {'city': 'Matsubara', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.56667, 'lon': 135.55}}, {'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'city': 'Sayama', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.51685, 'lon': 135.56298}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Fukaya', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 36.1771, 'lon': 139.26029}}, {'city': 'Hannō', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.85194, 'lon': 139.31806}}, {'city': 'Iruma', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.818, 'lon': 139.368}}, {'city': 'Koshigaya', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.89035, 'lon': 139.78916}}, {'city': 'Sayama', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.85295, 'lon': 139.41212}}, {'city': 'Masuda', 'state': 'Shimane', 'country': 'Japan', 'geoPoint': {'lat': 34.66667, 'lon': 131.85}}, {'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'city': 'Adachi City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.76318, 'lon': 139.80761}}, {'city': 'Bunkyo', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'city': 'Katsushika-ku', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.73333, 'lon': 139.85}}, {'city': 'Machida', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.54028, 'lon': 139.45083}}, {'city': 'Meguro City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6322, 'lon': 139.70174}}, {'city': 'Minato', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6581, 'lon': 139.7515}}, {'city': 'Nakano City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.70449, 'lon': 139.66946}}, {'city': 'Setagaya City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.64188, 'lon': 139.64715}}, {'city': 'Shinjuku', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.69115, 'lon': 139.70854}}, {'city': 'tabashi City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.74893, 'lon': 139.71497}}, {'city': 'Taitō City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.70749, 'lon': 139.7788}}, {'city': 'Toshima City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.76126, 'lon': 139.74491}}, {'city': 'Kurayoshi', 'state': 'Tottori', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 133.81667}}, {'city': 'Nanto', 'state': 'Toyama', 'country': 'Japan', 'geoPoint': {'lat': 36.51274, 'lon': 136.89352}}, {'city': 'Kinokawa', 'state': 'Wakayama', 'country': 'Japan', 'geoPoint': {'lat': 34.26973, 'lon': 135.41045}}, {'city': 'Tendō', 'state': 'Yamagata', 'country': 'Japan', 'geoPoint': {'lat': 38.35361, 'lon': 140.36972}}, {'city': 'Hagi', 'state': 'Yamaguchi', 'country': 'Japan', 'geoPoint': {'lat': 34.4, 'lon': 131.41667}}, {'city': 'Shūnan', 'state': 'Yamaguchi', 'country': 'Japan', 'geoPoint': {'lat': 34.08053, 'lon': 131.82564}}, {'city': 'Ube', 'state': 'Yamaguchi', 'country': 'Japan', 'geoPoint': {'lat': 33.94306, 'lon': 131.25111}}, {'city': 'Akita', 'country': 'Japan', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukushima', 'country': 'Japan', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Kagoshima', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kochi', 'country': 'Japan', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Nara', 'country': 'Japan', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'city': 'Niigata', 'country': 'Japan', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Okayama', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Ōita', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Yamanashi', 'country': 'Japan', 'geoPoint': {'lat': 35.67152, 'lon': 138.69827}}], 'overallOfficials': [{'name': 'Shoya Yamakawa', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}