Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT02168920
Status:
TERMINATED
Last Update Posted:
2017-10-16
First Post:
2014-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'whyStopped': 'It was difficult to secure enrollment of the targeted number of subjects.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-13', 'studyFirstSubmitDate': '2014-06-18', 'studyFirstSubmitQcDate': '2014-06-18', 'lastUpdatePostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CMAI', 'timeFrame': 'Baseline, 10 weeks', 'description': 'Change from baseline'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression of Severity （CGI-S）', 'timeFrame': 'Baseline, 10 weeks', 'description': 'Change from baseline'}, {'measure': 'Clinical Global Impression-Improvement (CGI-I)', 'timeFrame': '10 Weeks', 'description': 'Score after 10 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alzeheimer'], 'conditions': ["Agitation Associated With Dementia of the Alzheimer's Type"]}, 'descriptionModule': {'briefSummary': "To evaluate the efficacy (based on mean change in Cohen-Mansfield Agitation Inventory \\[CMAI\\] total score from baseline as the primary efficacy variable), dose-response, and safety of aripiprazole at 2, 3, and 6 mg/day in comparison with placebo in patients with agitation associated with Alzheimer's type dementia", 'detailedDescription': "This trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, comparison trial to assess the efficacy and safety of aripiprazole in patients with agitation associated with Alzheimer's type dementia. Screening period is 4 weeks. Patients are randomly assigned to one of 4 groups, and treatment period is 10 weeks. Period of post-treatment observation is 30 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients whose legal representatives can provide informed consent (Informed consent from the patients where possible).\n* Patients who satisfy both of the following diagnostic criteria:\n\n * Diagnosis of major neurocognitive disorder due to Alzheimer's disease according to Diagnostic and Statistical Manual of mental disorders (DSM-5)\n * Diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)\n* Hospitalized patients or care facility patients\n* Patients with an Mini-Mental State Examination (MMSE) score of 1 to 22\n\nExclusion Criteria:\n\n* Patients with complications of dementia or memory impairment other than Alzheimer's type dementia\n* Dementia patients with a Modified Hachinski Ischemic Score of 5 or higher\n* Patients with psychological symptoms or behavioral disorders that are clearly due to other medical conditions or substances\n* Patients with a complication or history of stroke or transient ischemic attack, except for asymptomatic stroke\n* Patients with heart failure classified as New York Heart Asscoiation (NYHA） III or IV\n* Patients who require drug therapy for arrhythmia or ischemic heart disease\n* Body weight of less than 30 kg\n* Patients with a high risk of suicide\n* Patients with a complication or history of seizure disorder\n* Patients with a complication or history of neuroleptic malignant syndrome, tardive dyskinesia, paralytic ileus, or rhabdomyolysis\n* Patients with thyroid disease (except if the disease has been stabilized with drug therapy for 3 months or longer prior to time of informed consent)"}, 'identificationModule': {'nctId': 'NCT02168920', 'briefTitle': "Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type", 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': "A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type", 'orgStudyIdInfo': {'id': '031-13-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aripiprazole, 2 mg/day', 'interventionNames': ['Drug: 2 mg/day']}, {'type': 'EXPERIMENTAL', 'label': 'Aripiprazole, 3 mg/day', 'interventionNames': ['Drug: 3 mg/day']}, {'type': 'EXPERIMENTAL', 'label': 'Aripiprazole, 6 mg/day', 'interventionNames': ['Drug: 6 mg/day']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo (0 mg/day)']}], 'interventions': [{'name': '2 mg/day', 'type': 'DRUG', 'description': 'Once daily for 10 weeks', 'armGroupLabels': ['Aripiprazole, 2 mg/day']}, {'name': '3 mg/day', 'type': 'DRUG', 'description': 'Once daily for 10 weeks', 'armGroupLabels': ['Aripiprazole, 3 mg/day']}, {'name': '6 mg/day', 'type': 'DRUG', 'description': 'Once daily for 10 weeks', 'armGroupLabels': ['Aripiprazole, 6 mg/day']}, {'name': 'Placebo (0 mg/day)', 'type': 'DRUG', 'description': 'Once daily for 10 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kanto Region', 'country': 'Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}