Trial · NCT01922258
Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
NCT01922258, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2020-07-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type. Trials, record NCT01922258. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01922258
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
- NCT number
- NCT01922258
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 270 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
- First posted
- 2013-08-14
- Last updated
- 2020-11-20
- Results first posted
- 2020-07-07
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 to Week 12/Early Termination in the Cohen-Mansfield Agitation Inventory (CMAI) Total Score | From screening to week 12/early termination | The CMAI is widely used in clinical research for evaluation of agitation associated with Alzheimer's dementia, with reliability and validity in both institutionalized and noninstitutionalized participants. It consists of 29 items, all rated on a 1 to 7 scale (1=Never and 7=Several times in an hour), with 1 being the "best" rating and 7 being the "worst" rating. The total score is the sum of ratings for all 29 items. The possible total scores range from 29 to 203. The total score will be unevaluable if less than 24 of the 29 items are recorded. If 24 to 28 of the 29 items are recorded, the total score will be the mean of the recorded items multiplied by 29 and rounded to the first decimal place. The mean change from baseline (Day 0) to week 12 in the CMAI total score is reported. Statistical comparison of interest was brexpiprazole flexible dose versus placebo, analyzed using a mixed-effect model repeated measure approach. A decrease in score indicates improvement in symptoms. |
| Secondary | Change in the Clinical Global Impression Severity of Illness (CGI-S) Score, as Related to Symptoms of Agitation | From screening to week 12/early termination | The severity of agitation for each participant was rated using the CGI-S. The investigator (or designee) answered the following question: "Considering your total clinical experience with this particular population, how mentally ill (as related to agitation) was the participant at the observation period?" Response choices 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. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale (1-7). The primary analysis used a mixed-effect model repeated measure approach. |
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 to Week 12/Early Termination in the Cohen-Mansfield Agitation Inventory (CMAI) Total Score | From screening to week 12/early termination | The intent-to-treat (ITT) population consisted of all participants in the randomized sample, who took at least 1 dose of the investigational medicinal product (IMP) and had a baseline and at least one postbaseline evaluation for the CMAI total score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Clinical Global Impression Severity of Illness (CGI-S) Score, as Related to Symptoms of Agitation | From screening to week 12/early termination | The intent-to-treat (ITT) population consisted of all participants in the randomized sample, who took at least 1 dose of the IMP and had a baseline and at least one postbaseline evaluation for the CMAI total score. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12/Early Termination in the Cohen-Mansfield Agitation Inventory (CMAI) Total Score | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | -18.9 | Standard Error 1.17 | units on a scale | |
| Change From Baseline to Week 12/Early Termination in the Cohen-Mansfield Agitation Inventory (CMAI) Total Score | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | -16.5 | Standard Error 1.13 | units on a scale | |
| Change in the Clinical Global Impression Severity of Illness (CGI-S) Score, as Related to Symptoms of Agitation | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | 4.54 | Standard Deviation 0.77 | units on a scale | |
| Change in the Clinical Global Impression Severity of Illness (CGI-S) Score, as Related to Symptoms of Agitation | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | 4.51 | Standard Deviation 0.74 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | 133 | |
| Overall Study | STARTED | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | 137 | |
| Overall Study | COMPLETED | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | 117 | |
| Overall Study | COMPLETED | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | 121 | |
| Overall Study | NOT COMPLETED | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | 16 | |
| Overall Study | NOT COMPLETED | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | 16 |
Source ClinicalTrials.gov
Adverse events34
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 | Somnolence | Nervous system disorders | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | 8 | 132 | |
| other | Somnolence | Nervous system disorders | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | 5 | 137 | |
| other | Dizziness | Nervous system disorders | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | 6 | 132 | |
| other | Dizziness | Nervous system disorders | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | 7 | 137 | |
| other | Headache | Nervous system disorders | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | 10 | 132 | |
| other | Headache | Nervous system disorders | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | 17 | 137 | |
| serious | Gastrointestinal haemorrhage | Gastrointestinal disorders | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | 0 | 132 | |
| serious | Gastrointestinal haemorrhage | Gastrointestinal disorders | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | 1 | 137 | |
| serious | Non-Cardiac Chest Pain | General disorders | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | 1 | 132 | |
| serious | Non-Cardiac Chest Pain | General disorders | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | 0 | 137 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | 0 | 132 |
| Total, all-cause mortality | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | 1 | 137 |
| Total, other adverse events | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | 24 | 132 |
| Total, other adverse events | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | 29 | 137 |
| Total, serious adverse events | Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) | 7 | 132 |
| Total, serious adverse events | Placebo (Flexible Dose Range 0.5 to 2 mg/Day) | 6 | 137 |
Source ClinicalTrials.gov
Papers6
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) vs Placebo (Flexible Dose Range 0.5 to 2 mg/Day): deaths from any cause | Trial comparisons |
| Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day) vs Placebo (Flexible Dose Range 0.5 to 2 mg/Day): serious adverse events | Trial comparisons |
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/NCT01922258
GET https://conductscience.org/api/trials/v1/NCT01922258/events?page=2