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

Otsuka

Status and phase

Completed

Phase 3

Conditions

Dementia, Alzheimer Type

Treatments

Drug: Placebo

Drug: Aripiprazole (BMS-337039)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01438060

CN138-006

Details and patient eligibility

About

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

Full 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.

Enrollment

232 patients

Sex

All

Ages

55 to 95 years old

Volunteers

No Healthy Volunteers

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