Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT00314912
Status:
UNKNOWN
Last Update Posted:
2007-07-16
First Post:
2006-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate 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': 'C001355', 'term': 'tramiprosate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 650}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-05'}, 'statusVerifiedDate': '2007-07', 'lastUpdateSubmitDate': '2007-07-13', 'studyFirstSubmitDate': '2006-04-13', 'studyFirstSubmitQcDate': '2006-04-13', 'lastUpdatePostDateStruct': {'date': '2007-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the long-term safety of Tramiprosate (3APS).'}], 'secondaryOutcomes': [{'measure': 'To provide additional long-term data on the efficacy of Tramiprosate (3APS).'}]}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this Phase III open-label extension study is to evaluate the long-term safety of Tramiprosate (3APS) in patients with mild to moderate Alzheimer's disease.", 'detailedDescription': 'Duration of treatment: 12 months. Patients who complete the Phase III clinical trial will be offered the opportunity to receive Tramiprosate (3APS) in an open-label extension study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have successfully completed the full 78-week duration of the double-blind CL-758007 study.\n* Male or female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).\n* Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.\n* The patient must be presenting a reasonably good nutritional status.\n* Signed inform consent from the patient or legal representative.\n\nExclusion Criteria:\n\nPatients will not be eligible to participate in the study if they meet any of the following criteria:\n\n* The patient participates in another drug trial during the study.\n* The patient with a clinically significant and/or uncontrolled condition or other significant medical disease.\n* The patient is unable to swallow medication tablets.'}, 'identificationModule': {'nctId': 'NCT00314912', 'briefTitle': "Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Bellus Health Inc. - a GSK company'}, 'officialTitle': "An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'CL-758017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tramiprosate (3APS)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Clinical Research Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bellus Health Inc. - a GSK company', 'class': 'INDUSTRY'}}}}