Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:23 PM
Study NCT ID:
NCT01024660
Status:
COMPLETED
Last Update Posted:
2011-02-08
First Post:
2009-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil
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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-06', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CogState Computerized Neurological Test Battery', 'timeFrame': 'Tl. of 25 times: 10 times between Days 3-14, 5 times between Days 36-42, 5 times between Days 64-70, four times between Days 92-97, 1 time on Day 98'}], 'secondaryOutcomes': [{'measure': 'Neuropsychological Test Battery (NTB)', 'timeFrame': 'Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97'}, {'measure': 'Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog)', 'timeFrame': 'Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97'}, {'measure': "Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)", 'timeFrame': 'Tl. of 4 times: Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Patients with Mild to Moderate Alzheimer's Disease"], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '23763450', 'type': 'DERIVED', 'citation': 'Karin A, Hannesdottir K, Jaeger J, Annas P, Segerdahl M, Karlsson P, Sjogren N, von Rosen T, Miller F. Psychometric evaluation of ADAS-Cog and NTB for measuring drug response. Acta Neurol Scand. 2014 Feb;129(2):114-22. doi: 10.1111/ane.12153. Epub 2013 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if there is improvement or measurable change in cognition after only one month of treatment with donepezil when using a computerized test battery. The results at one month will be compared with the results at 3 months to evaluate this.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of probable AD according to NINCDS-ADRDA criteria.\n* The patient should live with an appropriate caregiver at home, or in a community dwelling. A caregiver should be capable of accompanying the patient to clinic visits or attending study visits in the patient's home.\n* Patient and caregiver should understand, speak, and read local language.\n\nExclusion Criteria:\n\n* Significant neurological disease or dementia other than AD, e.g., mixed dementia, frontotemporal dementia, and Parkinson's Disease.\n* Females of child bearing potential\n* Impaired vision or hearing"}, 'identificationModule': {'nctId': 'NCT01024660', 'briefTitle': 'The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': "A Randomised, Double-blind, Placebo-controlled, Parallel Design, Multicentre Study in Patients With Mild to Moderate Alzheimer's Disease to Investigate the Effect on Cognitive Function as Measured by Repeated CogState Testing in Relation to Effects on Traditional Cognitive Measures After 12 Weeks", 'orgStudyIdInfo': {'id': 'D2285M00010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days)', 'interventionNames': ['Drug: Donepezil']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo to match Aricept']}], 'interventions': [{'name': 'Donepezil', 'type': 'DRUG', 'otherNames': ['Aricept'], 'description': '5 mg capsule, orally, once daily, first 14 days of treatment', 'armGroupLabels': ['1']}, {'name': 'Donepezil', 'type': 'DRUG', 'otherNames': ['Aricept'], 'description': '10 mg, orally, once daily, for remaining 70 days of treatment', 'armGroupLabels': ['1']}, {'name': 'Placebo to match Aricept', 'type': 'DRUG', 'description': 'Placebo capsule, orally, 84 days of treatment', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Gatineau', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Québec', 'country': 'Canada', 'facility': 'Reearch Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Callao', 'state': 'Lima', 'country': 'Peru', 'facility': 'Research Site'}, {'city': 'Callao', 'country': 'Peru', 'facility': 'Research Site', 'geoPoint': {'lat': -12.05162, 'lon': -77.13452}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Research Site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Chojnice', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.69554, 'lon': 17.55701}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Kalisz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.76109, 'lon': 18.09102}}, {'city': 'Piła', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.15145, 'lon': 16.73782}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Sopot', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 54.4418, 'lon': 18.56003}}, {'city': 'Ścinawa', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.41626, 'lon': 16.4251}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Roodepoort', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -26.1625, 'lon': 27.8725}}], 'overallOfficials': [{'name': 'Malene Jensen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Study Delievery Director, AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MSD', 'oldOrganization': 'AstraZeneca'}}}}