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

NCT01438060 | Completed Phase 3 Results

• 1 other identifier: CN138-006
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dementia, Alzheimer Type

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase

  The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.

  Baseline (Day 0), Week 10

Secondary Outcomes (41)

• Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase

  Baseline (Day 0), Weeks 1, 2, 3, 4, 6, and 8

• Change From Baseline in NPI Total Score in Acute Phase

  Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

• Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase

  Weeks 1, 2, 3, 4, 6, 8, and 10

• Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase

  Weeks 1, 2, 3, 4, 6, 8, and 10

• Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase

  Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10

Study Arms (2)

Aripiprazole (BMS-337039)

EXPERIMENTAL

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

Drug: Aripiprazole (BMS-337039)

Placebo

PLACEBO COMPARATOR

Double blind Acute Phase (Week 1 to Week 10)

Drug: Placebo

Interventions

Aripiprazole (BMS-337039) 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

Aripiprazole (BMS-337039)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• Otsuka America Pharmaceutical: collaborator

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of subjects analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 21, 2011
• Study Start: August 1, 2000
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 2, 2013
• Results First Posted: March 5, 2012

Record last verified: 2013-11