Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-08 @ 6:30 PM
Study NCT ID:
NCT00093951
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2004-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SGS742 in Patients With Mild to Moderate Alzheimer's Disease (AD)
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': 'C079148', 'term': '(3-aminopropyl)(n-butyl)phosphinic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-10', 'studyFirstSubmitDate': '2004-10-07', 'studyFirstSubmitQcDate': '2004-10-07', 'lastUpdatePostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Alzheimer disease', 'memory', 'cognition', 'GABA(B)receptor antagonist'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '15451390', 'type': 'BACKGROUND', 'citation': 'Froestl W, Gallagher M, Jenkins H, Madrid A, Melcher T, Teichman S, Mondadori CG, Pearlman R. SGS742: the first GABA(B) receptor antagonist in clinical trials. Biochem Pharmacol. 2004 Oct 15;68(8):1479-87. doi: 10.1016/j.bcp.2004.07.030.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this trial is to determine the effect of a new drug, SGS742, on memory and cognition in patients with mild to moderate Alzheimer's disease.", 'detailedDescription': "SGS742 is a GABA(B) receptor antagonist. It is an orally active drug and possesses neurochemical and psychopharmacologic features that suggest it could improve memory and cognition in humans. The primary objective of the SGS742 clinical trial will be to determine the effect of SGS742 on memory and cognition in individuals diagnosed with mild to moderate Alzheimer's disease. The duration of the study is 3 months with 5 clinic visits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 55 to 90 years of age\n* Diagnosed with mild to moderate Alzheimer's disease\n* Willing caregiver\n* In general good health\n\nExclusion Criteria:\n\n* Call 1-877-MY-MEMORY and ask to be referred to a study center located near you for entry criteria information.\n\nProhibited Meds:\n\n* Alzheimer's medications (Aricept, Exelon, Remydl, Nemenda)"}, 'identificationModule': {'nctId': 'NCT00093951', 'briefTitle': "SGS742 in Patients With Mild to Moderate Alzheimer's Disease (AD)", 'organization': {'class': 'NIH', 'fullName': 'National Institute on Aging (NIA)'}, 'officialTitle': "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Study of the Efficacy and Safety of SGS742 in Subjects With Mild to Moderate Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'IA0061'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SGS742', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Dedicated Clinical Research', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Northwest NeuroSpecialists, PLLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Trials Incorporated', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Margolin Brain Institute', 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