Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-04 @ 1:43 PM
Study NCT ID:
NCT00555204
Status:
TERMINATED
Last Update Posted:
2011-08-23
First Post:
2007-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of ABT-089 in Adults 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': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'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': 'C108326', 'term': 'pozanicline'}]}}, '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': 337}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'dispFirstSubmitDate': '2011-08-19', 'lastUpdateSubmitDate': '2011-08-19', 'studyFirstSubmitDate': '2007-11-07', 'dispFirstSubmitQcDate': '2011-08-19', 'studyFirstSubmitQcDate': '2007-11-07', 'dispFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': 'Baseline to Final Evaluation'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (how the body handles the study drug)', 'timeFrame': 'Baseline to Final Evaluation'}, {'measure': 'Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory)', 'timeFrame': 'Baseline to Final Evaluation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["mild to moderate Alzheimer's disease, memory, cognition, dementia"], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '25973909', 'type': 'DERIVED', 'citation': 'Lenz RA, Pritchett YL, Berry SM, Llano DA, Han S, Berry DA, Sadowsky CH, Abi-Saab WM, Saltarelli MD. Adaptive, dose-finding phase 2 trial evaluating the safety and efficacy of ABT-089 in mild to moderate Alzheimer disease. Alzheimer Dis Assoc Disord. 2015 Jul-Sep;29(3):192-9. doi: 10.1097/WAD.0000000000000093.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for Alzheimer's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient has mild to moderate Alzheimer's disease\n* Patient has been receiving a stable dose of an acetylcholinesterase inhibitor\n* Patient has a MMSE score between 12 and 26\n* Patient has a MHIS score of less than or equal to 4\n* Females must be postmenopausal for at least two years or surgically sterile\n* Patient has an identified, reliable, caregiver who will support him/her to ensure compliance with treatment and will accompany them to each outpatient visit\n\nExclusion Criteria:\n\n* Patient is living in a nursing home\n* Patient has a history of any significant neurologic disease other than Alzheimer's disease\n* Patient has any uncontrolled medical illness\n* Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence"}, 'identificationModule': {'nctId': 'NCT00555204', 'briefTitle': "Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': "A Randomized, Double-Blind, Placebo-Controlled Study Using a Bayesian Adaptive Design to Evaluate the Efficacy and Safety of ABT-089 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors", 'orgStudyIdInfo': {'id': 'M06-876'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: ABT-089']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: ABT-089']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'interventionNames': ['Drug: ABT-089']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'interventionNames': ['Drug: ABT-089']}, {'type': 'EXPERIMENTAL', 'label': 'E', 'interventionNames': ['Drug: ABT-089']}, {'type': 'EXPERIMENTAL', 'label': 'F', 'interventionNames': ['Drug: ABT-089']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'G', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'ABT-089', 'type': 'DRUG', 'description': '10 mg - capsules once daily for 12 weeks', 'armGroupLabels': ['B']}, {'name': 'ABT-089', 'type': 'DRUG', 'description': '5 mg - capsules once daily for 12 weeks', 'armGroupLabels': ['A']}, {'name': 'ABT-089', 'type': 'DRUG', 'description': '15 mg - capsules once daily for 12 weeks', 'armGroupLabels': ['C']}, {'name': 'ABT-089', 'type': 'DRUG', 'description': '20 mg - capsules once daily for 12 weeks', 'armGroupLabels': ['D']}, {'name': 'ABT-089', 'type': 'DRUG', 'description': '30 mg - capsules once daily for 12 weeks', 'armGroupLabels': ['E']}, {'name': 'ABT-089', 'type': 'DRUG', 'description': '35 mg - capsules once daily for 12 weeks', 'armGroupLabels': ['F']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo - capsules once daily for 12 weeks', 'armGroupLabels': ['G']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '90404', 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