Clinical trial NCT01438060 (phase 3, status: completed)
Conditions: dementia, alzheimer type
ICD codes: G30.8, G30.9, G30.0, G30.1
Drugs: aripiprazole (bms-337039), placebo
SMILES: ClC1=CC=CC(N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2)=C1Cl, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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