Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type

NCT ID: NCT01438060

Last Updated: 2013-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2010-07-31

Brief Summary

The primary objective of the study is to compare the efficacy of aripiprazole with placebo in patients with psychosis associated with Alzheimer's dementia.

Detailed Description

Open label Extension Phase: The 130-week Extension Phase was conducted to provide information regarding long-term safety and efficacy of aripiprazole in participants who were diagnosed at the onset of the Acute Phase with psychotic symptoms associated with dementia of the Alzheimer's type who responded to treatment in the 10-week Acute Phase of this study.

Treatment beyond 140 week: A country-specific amendment for France, allowed participants treated with aripiprazole who, according to the investigator's opinion, showed improvement at the Week 140 visit to continue treatment beyond 140 weeks. The termination was to be determined by clinical benefit to he participant.

Study design:

Acute Phase: Randomized, double-blind, placebo-controlled, flexible-dose, parallel-group study.

Extension Phase: Open label; flexible-dose.

Conditions

Dementia, Alzheimer Type

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aripiprazole (BMS-337039)

Double blind Acute Phase (Week 1 to Week 10), Open label Extension Phase (Week 11 to Week 140)

Group Type: EXPERIMENTAL

Aripiprazole (BMS-337039)

Intervention Type: DRUG

Acute Phase: Oral, Tablets (1 and 5 mg), Week 1-2: 2 mg, Week 3-4: 2 - 5 mg, Week 5-6: 2 - 10 mg, Weeks 7-10: 2 - 15 mg, Once daily, 10 weeks

Extension Phase: Oral, Tablets (1 and 5 mg), Week 11: 2 mg, Weeks 12-13: 2 - 5 mg, Weeks 14-15: 2 - 10 mg, Weeks 16-140: 2 - 15 mg, Once daily, 130 weeks

Placebo

Double blind Acute Phase (Week 1 to Week 10)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Acute Phase: Oral, Tablets, 0 mg, Once daily, 10 Weeks

Interventions

Aripiprazole (BMS-337039)

Acute Phase: Oral, Tablets (1 and 5 mg), Week 1-2: 2 mg, Week 3-4: 2 - 5 mg, Week 5-6: 2 - 10 mg, Weeks 7-10: 2 - 15 mg, Once daily, 10 weeks

Extension Phase: Oral, Tablets (1 and 5 mg), Week 11: 2 mg, Weeks 12-13: 2 - 5 mg, Weeks 14-15: 2 - 10 mg, Weeks 16-140: 2 - 15 mg, Once daily, 130 weeks

Intervention Type: DRUG

Placebo

Acute Phase: Oral, Tablets, 0 mg, Once daily, 10 Weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Non-institutionalized patients with a diagnosis of Alzheimer's disease as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria with symptoms of delusions or hallucinations, which have been present, at least intermittently for one month or longer
• Mini Mental State Examination (MMSE) score of 6 to 24 points
• Patients capable of self locomotion or locomotion with the aid of an assistive device
• Patients with an identified caregiver or proxy

For Extension Phase:

Eligible patients were males and females who had completed the 10-week Acute Phase in either treatment group; had a Week 10 Total Score of ≥ 6 on the NPI; and were, in the judgment of the investigator, deemed suitable for participation in the long-term trial.

Treatment beyond 140 weeks:

All subjects who completed the extension phase of CN138-006 in any French Investigational Site may be considered eligible for entry until they are no longer receiving clinical benefit, per the investigator's judgment

Exclusion Criteria

• Patients with an Axis I (DSM IV) diagnosis of:

• delirium
• amnestic disorders
• bipolar disorder
• schizophrenia or schizoaffective disorder
• mood disorder with psychotic features
• Patients with reversible causes of dementia
• Patients with psychotic symptoms continuously present since prior to the onset of the symptoms of dementia
• Patients with psychotic symptoms that are better accounted for by another general medical condition or by direct physiological effects of a substance
• Patients with a current major depressive episode with psychotic symptoms of hallucinations or delusions
• Patients with a diagnosis of dementia related to infection with the human immunodeficiency virus
• Patients with substance-induced persistent dementia
• Patients with dementia due to vascular causes, multi-infarct, head trauma, Pick's disease, Parkinson's disease, frontal or temporal dementia, Lewy body dementia, or any specific non-Alzheimer's type dementia
• Patients with seizure disorders
• Patients who have been refractory to neuroleptics used to treat psychotic symptoms in the past when treated for an adequate period with a therapeutic dose, unless permission is obtained from Bristol-Myers Squibb
• Patients who have met DSM-IV criteria for any significant substance use disorder within the 6 months prior to the start of screening

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Other Identifiers

CN138-006

Identifier Type: -

Identifier Source: org_study_id