Phase 3
N=208
Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type
Dementia, Alzheimer Type
Bottom Line
View on ClinicalTrials.gov: NCT01438060 ↗Enrolled (actual)
208
Serious AEs
29.3%
Results posted
Mar 2012
Primary outcome: Primary: Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase — 12.12; 12.29; -5.52; -6.55 Units on a scale — p=0.802
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aripiprazole (BMS-337039) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase |
12.12; 12.29; -5.52; -6.55 | 0.802 |
| SECONDARY Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase |
12.12; 12.29; -3.33; -2.26; -3.96; -3.81 | — |
| SECONDARY Change From Baseline in NPI Total Score in Acute Phase |
40.08; 39.82; -6.26; -4.13; -9.98; -8.40 | — |
| SECONDARY Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase |
24; 18; 37; 34; 45; 44 | 0.391 |
| SECONDARY Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase |
12; 11; 31; 29; 35; 33 | 0.753 |
| SECONDARY Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase |
4.80; 4.70; -0.80; -0.64; -0.84; -0.78 | — |
| SECONDARY Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase |
16.58; 17.06; -1.81; -1.64; -3.25; -3.04 | — |
| SECONDARY Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase |
4.84; 4.83; -0.19; -0.10; -0.29; -0.19 | — |
| SECONDARY CGI Improvement Score in Acute Phase |
3.81; 3.96; 3.55; 3.71; 3.37; 3.49 | 0.133 |
| SECONDARY Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase |
43.42; 43.63; -4.65; -5.82; -5.80; -7.44 | — |
| SECONDARY Change From Baseline in Mini Mental State Examination (MMSE) Total Score in Acute Phase |
14.13; 14.35; 0.53; -0.81 | 0.733 |
| SECONDARY Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions |
7.85; 8.11; -2.37; -1.61; -2.84; -2.72 | — |
| SECONDARY Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations |
4.27; 4.18; -0.98; -0.65; -1.15; -1.09 | — |
| SECONDARY Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression |
3.52; 4.04; -0.34; 0.10; -1.16; -0.69 | — |
| SECONDARY Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria |
3.27; 2.28; 0.21; -0.04; -0.44; -0.36 | — |
| SECONDARY Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety |
3.64; 3.17; 0.02; 0.05; -0.08; 0.08 | — |
| SECONDARY Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference |
4.14; 3.47; 0.03; -0.70; -0.48; -0.76 | — |
| SECONDARY Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria |
0.56; 0.73; -0.48; -0.26; -0.37; -0.18 | — |
| SECONDARY Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition |
0.98; 1.36; -0.14; -0.39; -0.42; -0.44 | — |
| SECONDARY Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability |
3.73; 4.36; -0.73; -0.09; -0.89; -0.69 | — |
| SECONDARY Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior |
3.67; 3.61; -0.66; 0.18; -0.84; -0.51 | — |
| SECONDARY Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors |
1.78; 1.47; -0.24; -0.18; -0.36; -0.21 | — |
| SECONDARY Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep |
2.67; 3.03; -0.10; -0.07; -0.20; -0.07 | — |
| SECONDARY Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase |
14.41; 14.47; 0.02; -0.35; -0.15; -0.06 | — |
| SECONDARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase |
0.87; 0.93; -0.10; -0.17; -0.05; -0.08 | — |
| SECONDARY Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase |
0.20; 0.19; -0.06; -0.06; -0.02; -0.05 | — |
| SECONDARY Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase |
2; 0; 1; 2; 1; 1 | — |
| SECONDARY Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase |
53; 67; 9; 16; 0; 4 | — |
| SECONDARY Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase |
1; 3; 1; 1; 1; 0 | — |
| SECONDARY Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase |
5; 5; 1; 1; 6; 2 | — |
| SECONDARY Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase |
3; 1; 2; 1; 10; 7 | — |
| SECONDARY Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase |
12.312; -8.589; -8.993; -8.270; -8.582; -9.232 | — |
| SECONDARY Clinical Global Impression (CGI) Improvement Score During Extension Phase |
2.873; 2.709; 2.625; 2.552; 2.707; 2.636 | — |
| SECONDARY Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase |
0.95; 0.25; 0.09; 0.02; -0.12; -0.01 | — |
| SECONDARY Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase |
14.34; 0.62; 1.24; 1.25; 1.14; 2.01 | — |
| SECONDARY Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase |
0.14; 0.04; 0.03; 0.04; 0.06; 0.06 | — |
| SECONDARY Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase |
2; 3; 14; 8; 8; 1 | — |
| SECONDARY Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase |
41; 59; 148; 66 | — |
| SECONDARY Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase |
6; 9; 6; 7; 1; 4 | — |
| SECONDARY Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase |
5; 1; 4; 5; 10; 2 | — |
| SECONDARY Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase |
0; 1; 2; 1; 56; 8 | — |
| SECONDARY Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks |
7; 1; 1; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT01438060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.