Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 12:30 PM
Study NCT ID:
NCT01073228
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2010-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Cognitive Function Study of EVP-6124 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'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain 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': 'C573817', 'term': '7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 409}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'dispFirstSubmitDate': '2013-02-19', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-28', 'studyFirstSubmitDate': '2010-02-19', 'dispFirstSubmitQcDate': '2013-02-19', 'studyFirstSubmitQcDate': '2010-02-22', 'dispFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)", 'timeFrame': 'Day -7, Baseline, 4, 12, 18, 23 Weeks'}], 'secondaryOutcomes': [{'measure': "Alzheimer's Disease Assessment Scale-Cognitive subscale-11", 'timeFrame': '4, 12, 18, 23 Weeks'}, {'measure': 'Controlled Oral Word Association Test', 'timeFrame': 'Day -7, Baseline, 4, 12, 18, 23 Weeks'}, {'measure': 'Category Fluency Test', 'timeFrame': 'Day -7, Baseline, 4, 12, 18, 23 Weeks'}, {'measure': 'Clinical Dementia Rating Scale Sum of Boxes', 'timeFrame': 'Day -7, Baseline, 4, 12, 18, 23 Weeks'}, {'measure': "Alzheimer's Disease Cooperative Study-Activities of Daily Living", 'timeFrame': 'Baseline, 4, 12, 18, 23 Weeks'}, {'measure': 'Neuropsychiatric Inventory', 'timeFrame': 'Baseline, 12, 23 Weeks'}, {'measure': 'Mini-Mental State Exam', 'timeFrame': 'Day -7, Baseline, 4, 12, 18, 23 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'Central Nervous System diseases', 'Cognition'], 'conditions': ["Alzheimer's Disease", 'Central Nervous System Diseases', 'Cognition']}, 'descriptionModule': {'briefSummary': "This study is being conducted to determine the safety and effect on cognitive function of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease.", 'detailedDescription': "This is a randomized, double-blind, placebo-controlled, parallel, 24-week, Phase 2 safety/efficacy study in which three dose levels of EVP-6124 or placebo will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for mild to moderate probable Alzheimer's disease who are either receiving treatment with AChEI medication at a stable dose or who are not presently taking any AChEI or memantine co-medication.\n\nPatients will be randomized to one of the following groups: 0.3 mg, 1 mg or 2 mg or Placebo. Approximately 400 subjects will be randomized to the 4 treatment groups. Study drug will be supplied as capsules and will be orally administered once daily for a total of 24 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects with Probable Alzheimer's disease\n* Mini-Mental State Examination (MMSE) score of 14 to 24 inclusive at screening and a CDR-SB score ≥2 at the screening assessment\n* Modified Hachinski Ischemic Score (mHIS) ≤4 at screening\n* Female subjects are ≥1 year post-menopausal or are surgically sterile\n* Caregiver available; if not living in the same household, caregiver sees subject at least four times each week\n* Subject living at home, senior residential setting, or an institutional setting without the need for continuous nursing care\n* General health status acceptable for participation in a 24 week clinical trial be administered\n\nExclusion Criteria:\n\nGeneral\n\n* Participation in another therapeutic clinical trial within 30 days before Baseline\n* Prior participation in an amyloid vaccination clinical study\n* Inability to swallow capsules\n* Likely inability to complete 24 week study\n* Inability to be ≥75% compliant with single-blind placebo run-in medication\n* Inability to adequately perform cognitive tests\n* History of significant cardiovascular disease\n* Major depression\n* Psychosis\n* History of stroke within 18 months of screening\n* Head trauma\n* Inability to perform any screening or baseline evaluations"}, 'identificationModule': {'nctId': 'NCT01073228', 'briefTitle': "Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'FORUM Pharmaceuticals Inc'}, 'officialTitle': "A Randomized, Double-blind, Placebo-Controlled, Parallel, 24-Week, Phase 2 Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Subjects With Mild to Moderate Probable Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'EVP-6124-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EVP-6124 0.3 mg', 'description': 'one 0.3 mg capsule every day for 183 days', 'interventionNames': ['Drug: EVP-6124']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EVP-6124 1 mg', 'description': 'one 1 mg capsule every day for 183 days', 'interventionNames': ['Drug: EVP-6124']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EVP-6124 2 mg', 'description': 'one 2 mg capsule every day for 183 days', 'interventionNames': ['Drug: EVP-6124']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo every day for 183 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'EVP-6124', 'type': 'DRUG', 'armGroupLabels': ['EVP-6124 0.3 mg', 'EVP-6124 1 mg', 'EVP-6124 2 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 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'facility': 'Clinical Site 4', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Clinical Site 5', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '700282', 'city': 'Iași', 'country': 'Romania', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '410154', 'city': 'Oradea', 'country': 'Romania', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'city': 'Târgu Mureş', 'country': 'Romania', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '420064', 'city': "Kazan'", 'country': 'Russia', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '115552', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Clinical Site 1', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Clinical Site 2', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '190005', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Clinical Site 1', 'geoPoint': {'lat': 59.93863, 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'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FORUM Pharmaceuticals Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'INC Research Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}