Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type
Condition: Dementia, Alzheimer Type
MeSH terms: Dementia; Alzheimer Disease
Intervention: Aripiprazole (BMS-337039); Placebo
Intervention description: 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; Acute Phase: Oral, Tablets, 0 mg, Once daily, 10 Weeks
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 232.0
Sex: All
Minimum age: 55 Years
Maximum age: 95 Years
Healthy volunteers: No

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.
    

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