Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-04 @ 3:47 AM
Study NCT ID:
NCT00348192
Status:
COMPLETED
Last Update Posted:
2009-06-02
First Post:
2006-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SB-742457 And Donepezil In Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Hungary']}, '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': 'C548140', 'term': '3-benzenesulfonyl-8-piperazin-1-ylquinoline'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'lastUpdateSubmitDate': '2009-05-28', 'studyFirstSubmitDate': '2006-06-30', 'studyFirstSubmitQcDate': '2006-06-30', 'lastUpdatePostDateStruct': {'date': '2009-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cognition and function after 24 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change in behavioral symptoms, activities of daily living and caregiver burden after 24 weeks Changes in all symptoms at 8 and 12 weeks Safety and tolerability PK (pharmacokinetic) profiling. Efficacy related to ApoE and HTR6 status'}]}, 'conditionsModule': {'keywords': ["Alzheimer's Disease", 'cognition global functioning', 'symptomatic', 'SB-742457'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '20872778', 'type': 'DERIVED', 'citation': 'Maher-Edwards G, Dixon R, Hunter J, Gold M, Hopton G, Jacobs G, Hunter J, Williams P. SB-742457 and donepezil in Alzheimer disease: a randomized, placebo-controlled study. Int J Geriatr Psychiatry. 2011 May;26(5):536-44. doi: 10.1002/gps.2562. Epub 2010 Sep 24.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it has on the symptoms of mild to moderate Alzheimer's Disease. SB-742457 is a new treatment which is thought to increase the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's Disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Clinical diagnosis of probable mild-to-moderate Alzheimer's Disease as determined by the NINCDS-ADRDA and DSM-IV criteria with an MMSE score of 12-24.\n* Subjects and their caregivers must provide informed consent prior to study entry.\n* Adequate blood pressure and laboratory values.\n\nExclusion criteria:\n\n* Females of child-bearing potential.\n* Have other causes of dementia such as vascular damage, depression, bipolar affective disorder, schizophrenia, syphilis, vitamin B12 deficiency or thyroid deficiency.\n* Subjects taking medication for Alzheimers disease or centrally acting agents which might impact study outcomes.\n* Subjects taking agents for which there is a theoretical risk of interaction with SB-742457 or donepezil.\n* Subjects with conditions which might be exacerbated by exposure to donepezil.\n* Subjects with known hypersensitivity to sunlight or seizures."}, 'identificationModule': {'nctId': 'NCT00348192', 'briefTitle': "SB-742457 And Donepezil In Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Effects of SB-742457, Donepezil and Placebo on Cognition in Subjects With Mild to Moderate Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'AZ3106242'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SB-742457', 'type': 'DRUG'}, {'name': 'donepezil', 'type': 'DRUG', 'otherNames': ['SB-742457']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-6060', 'city': 'Hall in Tirol', 'country': 'Austria', 'facility': 'GSK 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'7500710', 'city': 'Providencia / Santiago', 'state': 'Región Metro de Santiago', 'country': 'Chile', 'facility': 'GSK Investigational Site'}, {'zip': '7560356', 'city': 'Santiago', 'state': 'Región Metro de Santiago', 'country': 'Chile', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '10617', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '51014', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '73760', 'city': 'Ostfildern', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.72704, 'lon': 9.24954}}, {'zip': '35625', 'city': 'Hüttenberg', 'state': 'Hesse', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.51453, 'lon': 8.62189}}, {'zip': '28832', 'city': 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'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'GSK Clinical Trials, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'GSK'}}}}