Trial · NCT01438060
Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type
NCT01438060, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2012-03-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type. Trials, record NCT01438060. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01438060
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type
- NCT number
- NCT01438060
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 232 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Dementia, Alzheimer Type
- Interventions
- Aripiprazole (BMS-337039), Placebo
- First posted
- 2011-09-21
- Last updated
- 2013-12-02
- Results first posted
- 2012-03-05
- 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
Source ClinicalTrials.gov
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase | Baseline (Day 0), Week 10 | 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. |
| Secondary | 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 | 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. |
| Secondary | Change From Baseline in NPI Total Score in Acute Phase | Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10 | 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 Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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 Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement. |
| Secondary | 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 | 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 Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement. |
| Secondary | Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase | Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10 | 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 total NPI Caregiver Distress Score is calculated by adding the 12 Caregiver Distress Individual Item Scores, to yield a possible total score of 0 to 60. Lower score=less severity. A negative change score from baseline indicates improvement. |
| Secondary | Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase | Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10 | The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Severity scale is a 7-point scale that requires the clinician to rate the severity of the illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. The assessment is based on severity of mental illness at the time of rating, 0=not assessed, 1=normal, 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill. |
| Secondary | CGI Improvement Score in Acute Phase | Weeks 1, 2, 3, 4, 6, 8, and 10 | The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. |
| Secondary | Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase | Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10 | The BPRS is designed to measure clinical change in participants and is used as a global measure of psychopathology. The BPRS includes 18 items with items devoted to hallucinatory behavior, suspiciousness, unusual thought content, etc. BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. A negative change score signifies improvement. |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase | Baseline (Day 0), Week 10 | Last Observation Carried forward (LOCF) data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2) | Units on a scale | MEAN |
| SECONDARY | 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 | LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2) | Units on Scale | MEAN |
| SECONDARY | Change From Baseline in NPI Total Score in Acute Phase | Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10 | LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2) | Units on a Scale | MEAN |
| SECONDARY | 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 | LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2) | Participants | NUMBER |
| SECONDARY | 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 | LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2) | Participants | NUMBER |
| SECONDARY | 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 | LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2) | Unit on a Scale | MEAN |
| SECONDARY | Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase | Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10 | LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2) | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase | Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10 | LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2). An additional participant did not have CGI-Severity score and was not included in the analysis | Units on Scale | MEAN |
| SECONDARY | CGI Improvement Score in Acute Phase | Weeks 1, 2, 3, 4, 6, 8, and 10 | LOCF data set, efficacy sample. n = Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2) | Units on Scale | MEAN |
| SECONDARY | Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase | Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10 | LOCF data set, efficacy sample. n = Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2) | Unit on Scale | MEAN |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group629
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase | Placebo | Baseline (Day 0) | 12.12 | Standard Error 0.60 | Units on a scale |
| Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase | Aripiprazole | Baseline (Day 0) | 12.29 | Standard Error 0.59 | Units on a scale |
| Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase | Placebo | Mean Change from Baseline at Week 10 | -5.52 | Standard Error 0.66 | Units on a scale |
| Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase | Aripiprazole | Mean Change from Baseline at Week 10 | -6.55 | Standard Error 0.65 | Units on a scale |
| Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase | Placebo | Baseline (Day 0) | 12.12 | 95% Confidence Interval 0.60 | Units on Scale |
| Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase | Aripiprazole | Baseline (Day 0) | 12.29 | 95% Confidence Interval 0.59 | Units on Scale |
| Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase | Placebo | Week 1 | -3.33 | 95% Confidence Interval 0.53 | Units on Scale |
| Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase | Aripiprazole | Week 1 | -2.26 | 95% Confidence Interval 0.52 | Units on Scale |
| Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase | Placebo | Week 2 | -3.96 | 95% Confidence Interval 0.67 | Units on Scale |
| Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase | Aripiprazole | Week 2 | -3.81 | 95% Confidence Interval 0.66 | Units on Scale |
1 to 10 of 629Source ClinicalTrials.gov
See all 629 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Acute Phase: Double-blind, 10 Weeks | STARTED | Placebo | 102 | |
| Acute Phase: Double-blind, 10 Weeks | STARTED | Aripiprazole | 106 | |
| Acute Phase: Double-blind, 10 Weeks | COMPLETED | Placebo | 84 | |
| Acute Phase: Double-blind, 10 Weeks | COMPLETED | Aripiprazole | 88 | |
| Acute Phase: Double-blind, 10 Weeks | NOT COMPLETED | Placebo | 18 | |
| Acute Phase: Double-blind, 10 Weeks | NOT COMPLETED | Aripiprazole | 18 | |
| Extension Phase: Week 10 to Week 130 | STARTED | Placebo | 80 | |
| Extension Phase: Week 10 to Week 130 | STARTED | Aripiprazole | 81 | |
| Extension Phase: Week 10 to Week 130 | COMPLETED | Placebo | 22 | |
| Extension Phase: Week 10 to Week 130 | COMPLETED | Aripiprazole | 25 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events333
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | CONSTIPATION | Gastrointestinal disorders | 1 Double Blind Aripiprazole | 2 | 105 | |
| other | CONSTIPATION | Gastrointestinal disorders | 2 Double Blind Placebo | 0 | 102 | |
| other | CONSTIPATION | Gastrointestinal disorders | 3 Ext - Aripiprazole | 10 | 161 | |
| other | OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | 1 Double Blind Aripiprazole | 3 | 105 | |
| other | OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | 2 Double Blind Placebo | 0 | 102 | |
| other | OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | 3 Ext - Aripiprazole | 10 | 161 | |
| other | SOMNOLENCE | Nervous system disorders | 1 Double Blind Aripiprazole | 8 | 105 | |
| other | SOMNOLENCE | Nervous system disorders | 2 Double Blind Placebo | 2 | 102 | |
| other | SOMNOLENCE | Nervous system disorders | 3 Ext - Aripiprazole | 30 | 161 | |
| other | URINARY TRACT INFECTION | Infections and infestations | 1 Double Blind Aripiprazole | 8 | 105 |
1 to 10 of 333Source ClinicalTrials.gov
See all 333 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1 Double Blind Aripiprazole | ||
| Total, all-cause mortality | 2 Double Blind Placebo | ||
| Total, all-cause mortality | 3 Ext - Aripiprazole | ||
| Total, other adverse events | 1 Double Blind Aripiprazole | 31 | 105 |
| Total, other adverse events | 2 Double Blind Placebo | 27 | 102 |
| Total, other adverse events | 3 Ext - Aripiprazole | 101 | 161 |
| Total, serious adverse events | 1 Double Blind Aripiprazole | 16 | 105 |
| Total, serious adverse events | 2 Double Blind Placebo | 8 | 102 |
| Total, serious adverse events | 3 Ext - Aripiprazole | 84 | 161 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01438060
GET https://conductscience.org/api/trials/v1/NCT01438060/registered?page=2