Trial · NCT03724942
Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
NCT03724942, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type. Trials, record NCT03724942. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03724942
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
- NCT number
- NCT03724942
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 164 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Agitation Associated With Dementia of the Alzheimer's Type
- Interventions
- Brexpiprazole
- First posted
- 2018-10-30
- Last updated
- 2024-09-19
- Results first posted
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs) | From baseline to week 14 | This trial enrolled subjects rolled over from Trial 331-102-00088, and the safety of brexpiprazole when administered for a maximum of 24 weeks (including the treatment period of Trial 331-102-00088) was evaluated. |
| Secondary | Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 Weeks After Dosing | Baseline and 14 weeks after dosing | The CMAI assessed the frequency of agitated behaviors in elderly persons, such as hitting, cursing, and restlessness. It consisted 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 was 29, and the maximum possible CMAI total score was 203. A decrease in score indicated improvement in symptoms. |
| Secondary | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 Weeks After Dosing. | Baseline and 14 weeks after dosing. | 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 indicated improvement in symptoms. |
| Secondary | Clinical Global Impression of Improvement (CGI-I) Score at 14 Weeks After Dosing | 14 weeks after dosing. | The CGI-I Scale was clinician-rated scale which assessed the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs) | From baseline to week 14 | The safety analysis set comprised subjects who have received at least 1 dose of the IMP. | Percentage of percipitante | NUMBER |
| SECONDARY | Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 Weeks After Dosing | Baseline and 14 weeks after dosing | The efficacy analysis set will comprise subjects who have received at least 1 dose of the IMP and from whom CMAI total scores have been obtained at baseline and at least 1 time point after initiation of treatment. | Units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 Weeks After Dosing. | Baseline and 14 weeks after dosing. | The efficacy analysis set will comprise subjects who have received at least 1 dose of the IMP and from whom CMAI total scores have been obtained at baseline and at least 1 time point after initiation of treatment. | Units on a scale | MEAN |
| SECONDARY | Clinical Global Impression of Improvement (CGI-I) Score at 14 Weeks After Dosing | 14 weeks after dosing. | The efficacy analysis set will comprise subjects who have received at least 1 dose of the IMP and from whom CMAI total scores have been obtained at baseline and at least 1 time point after initiation of treatment. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs) | ROLLOVER BREX | 90.2 | Percentage of percipitante | ||
| The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs) | ROLLOVER PLACEBO | 90.3 | Percentage of percipitante | ||
| Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 Weeks After Dosing | ROLLOVER BREX | -2.5 | Standard Deviation 9.9 | Units on a scale | |
| Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 Weeks After Dosing | ROLLOVER PLACEBO | -6.4 | Standard Deviation 9.3 | Units on a scale | |
| Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 Weeks After Dosing. | ROLLOVER BREX | -0.2 | Standard Deviation 0.8 | Units on a scale | |
| Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 Weeks After Dosing. | ROLLOVER PLACEBO | -0.4 | Standard Deviation 1.1 | Units on a scale | |
| Clinical Global Impression of Improvement (CGI-I) Score at 14 Weeks After Dosing | ROLLOVER BREX | 3.1 | Standard Deviation 1.2 | Units on a scale | |
| Clinical Global Impression of Improvement (CGI-I) Score at 14 Weeks After Dosing | ROLLOVER PLACEBO | 2.7 | Standard Deviation 1.1 | 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 | ROLLOVER BREX | 102 | |
| Overall Study | STARTED | ROLLOVER PLACEBO | 62 | |
| Overall Study | COMPLETED | ROLLOVER BREX | 73 | |
| Overall Study | COMPLETED | ROLLOVER PLACEBO | 44 | |
| Overall Study | NOT COMPLETED | ROLLOVER BREX | 29 | |
| Overall Study | NOT COMPLETED | ROLLOVER PLACEBO | 18 |
Source ClinicalTrials.gov
Adverse events128
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 | Dry eye | Eye disorders | ROLLOVER BREX | 0 | 102 | |
| other | Dry eye | Eye disorders | ROLLOVER PLACEBO | 2 | 62 | |
| other | Constipation | Gastrointestinal disorders | ROLLOVER BREX | 8 | 102 | |
| other | Constipation | Gastrointestinal disorders | ROLLOVER PLACEBO | 3 | 62 | |
| other | Diarrhoea | Gastrointestinal disorders | ROLLOVER BREX | 2 | 102 | |
| other | Diarrhoea | Gastrointestinal disorders | ROLLOVER PLACEBO | 2 | 62 | |
| other | Salivary hypersecretion | Gastrointestinal disorders | ROLLOVER BREX | 6 | 102 | |
| other | Salivary hypersecretion | Gastrointestinal disorders | ROLLOVER PLACEBO | 4 | 62 | |
| other | Vomiting | Gastrointestinal disorders | ROLLOVER BREX | 1 | 102 | |
| other | Vomiting | Gastrointestinal disorders | ROLLOVER PLACEBO | 2 | 62 |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ROLLOVER BREX | 0 | 102 |
| Total, all-cause mortality | ROLLOVER PLACEBO | 1 | 62 |
| Total, other adverse events | ROLLOVER BREX | 90 | 102 |
| Total, other adverse events | ROLLOVER PLACEBO | 55 | 62 |
| Total, serious adverse events | ROLLOVER BREX | 7 | 102 |
| Total, serious adverse events | ROLLOVER PLACEBO | 4 | 62 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40290781 | DERIVED |
Source PubMed
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 |
|---|---|
| ROLLOVER BREX vs ROLLOVER PLACEBO: deaths from any cause | Trial comparisons |
| ROLLOVER BREX vs ROLLOVER PLACEBO: 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/NCT03724942
GET https://conductscience.org/api/trials/v1/NCT03724942/events?page=2