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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: Otsuka America Pharmaceutical
• Treatments: Aripiprazole

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