Trial · NCT01862640
A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation
NCT01862640, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2020-06-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation. Trials, record NCT01862640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01862640
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation
- NCT number
- NCT01862640
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 433 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Agitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
- Interventions
- Brexpiprazole, OPC-34712, Placebo Oral Tablet
- First posted
- 2013-05-24
- Last updated
- 2020-12-31
- Results first posted
- 2020-06-16
- Limitations and caveats
- None reported
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline In The Cohen-Mansfield Agitation Inventory (CMAI) Total Score After 12 Weeks Of Brexpiprazole Treatment | Baseline, Week 12/Early Termination (ET) | To compare the efficacy of 2 fixed doses (1 mg/day and 2 mg/day) of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type, by the assessment of CMAI after 12 weeks of treatment. The CMAI assesses the frequency of agitated behaviors in elderly persons, such as hitting, cursing, and restlessness. It consists of 29 items all rated on a 1 to 7 scale with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score is 29, and the maximum possible CMAI total score is 203. A decrease in score indicates improvement in symptoms. To control the overall type I error at 0.05 level when making 2 comparisons of brexpiprazole doses versus placebo, statistical testing was carried out using a hierarchical testing procedure in the order of: 1) comparison of 2 mg/day brexpiprazole versus placebo, and 2) comparison of 1 mg/day brexpiprazole versus placebo. |
| Secondary | Change From Baseline In The Clinical Global Impression-Severity Of Illness (CGI-S) Score, As Related To Symptoms Of Agitation After 12 Weeks Of Brexpiprazole Treatment | Baseline, Week 12/ET | To compare the efficacy of 2 fixed doses (1 mg/day and 2 mg/day) of brexpiprazole with placebo in participants with agitation associated with Alzheimer's dementia, by the assessment of CGI-S score after 12 weeks of treatment. The CGI-S was used to rate the severity of agitation. Scores were: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. A decrease in score indicates improvement in symptoms. |
Source ClinicalTrials.gov
Outcomes2
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 The Cohen-Mansfield Agitation Inventory (CMAI) Total Score After 12 Weeks Of Brexpiprazole Treatment | Baseline, Week 12/Early Termination (ET) | The modified intention-to-treat population consisted of all participants in the randomized sample who took at least 1 dose of IMP (excluding 20 subjects randomized to Brexpiprazole 0.5 mg/day, as doses lower than 1 mg/day were unlikely to be efficacious) and had a baseline and at least 1 post baseline evaluation for the CMAI total score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline In The Clinical Global Impression-Severity Of Illness (CGI-S) Score, As Related To Symptoms Of Agitation After 12 Weeks Of Brexpiprazole Treatment | Baseline, Week 12/ET | The modified intention-to-treat population consisted of all participants in the randomized sample who took at least 1 dose of IMP (excluding 20 participants randomized to Brexpiprazole 0.5 mg/day) and had a baseline and at least 1 post baseline evaluation for the CMAI total score. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
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 The Cohen-Mansfield Agitation Inventory (CMAI) Total Score After 12 Weeks Of Brexpiprazole Treatment | Brexpiprazole 2 mg/Day | -21.6 | Standard Error 1.32 | units on a scale | |
| Change From Baseline In The Cohen-Mansfield Agitation Inventory (CMAI) Total Score After 12 Weeks Of Brexpiprazole Treatment | Brexpiprazole 1 mg/Day | -17.6 | Standard Error 1.33 | units on a scale | |
| Change From Baseline In The Cohen-Mansfield Agitation Inventory (CMAI) Total Score After 12 Weeks Of Brexpiprazole Treatment | Placebo | -17.8 | Standard Error 1.34 | units on a scale | |
| Change From Baseline In The Clinical Global Impression-Severity Of Illness (CGI-S) Score, As Related To Symptoms Of Agitation After 12 Weeks Of Brexpiprazole Treatment | Brexpiprazole 2 mg/Day | -1.29 | Standard Deviation 1.05 | units on a scale | |
| Change From Baseline In The Clinical Global Impression-Severity Of Illness (CGI-S) Score, As Related To Symptoms Of Agitation After 12 Weeks Of Brexpiprazole Treatment | Brexpiprazole 1 mg/Day | -1.04 | Standard Deviation 1.12 | units on a scale | |
| Change From Baseline In The Clinical Global Impression-Severity Of Illness (CGI-S) Score, As Related To Symptoms Of Agitation After 12 Weeks Of Brexpiprazole Treatment | Placebo | -1.08 | Standard Deviation 0.89 | units on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brexpiprazole 0.5 mg/Day | 20 | |
| Overall Study | STARTED | Brexpiprazole 1 mg/Day | 137 | |
| Overall Study | STARTED | Brexpiprazole 2 mg/Day | 140 | |
| Overall Study | STARTED | Placebo | 136 | |
| Overall Study | COMPLETED | Brexpiprazole 0.5 mg/Day | 13 | |
| Overall Study | COMPLETED | Brexpiprazole 1 mg/Day | 121 | |
| Overall Study | COMPLETED | Brexpiprazole 2 mg/Day | 122 | |
| Overall Study | COMPLETED | Placebo | 121 | |
| Overall Study | NOT COMPLETED | Brexpiprazole 0.5 mg/Day | 7 | |
| Overall Study | NOT COMPLETED | Brexpiprazole 1 mg/Day | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events252
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 | Anaemia | Blood and lymphatic system disorders | Brexpiprazole 0.5 mg/Day | 1 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Brexpiprazole 1 mg/Day | 1 | 137 | |
| other | Anaemia | Blood and lymphatic system disorders | Brexpiprazole 2 mg/Day | 2 | 140 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 135 | |
| other | Constipation | Gastrointestinal disorders | Brexpiprazole 0.5 mg/Day | 1 | 20 | |
| other | Constipation | Gastrointestinal disorders | Brexpiprazole 1 mg/Day | 1 | 137 | |
| other | Constipation | Gastrointestinal disorders | Brexpiprazole 2 mg/Day | 5 | 140 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 135 | |
| other | Salivary Hypersecretion | Gastrointestinal disorders | Brexpiprazole 0.5 mg/Day | 1 | 20 | |
| other | Salivary Hypersecretion | Gastrointestinal disorders | Brexpiprazole 1 mg/Day | 0 | 137 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brexpiprazole 0.5 mg/Day | 2 | 20 |
| Total, all-cause mortality | Brexpiprazole 1 mg/Day | 2 | 137 |
| Total, all-cause mortality | Brexpiprazole 2 mg/Day | 1 | 140 |
| Total, all-cause mortality | Placebo | 0 | 135 |
| Total, other adverse events | Brexpiprazole 0.5 mg/Day | 11 | 20 |
| Total, other adverse events | Brexpiprazole 1 mg/Day | 27 | 137 |
| Total, other adverse events | Brexpiprazole 2 mg/Day | 43 | 140 |
| Total, other adverse events | Placebo | 29 | 135 |
| Total, serious adverse events | Brexpiprazole 0.5 mg/Day | 5 | 20 |
| Total, serious adverse events | Brexpiprazole 1 mg/Day | 11 | 137 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers12
The papers the trial lists on ClinicalTrials.gov.
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/NCT01862640
GET https://conductscience.org/api/trials/v1/NCT01862640/events?page=2