Trial · NCT03620981

Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

NCT03620981, Phase 2, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2024-11-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type. Trials, record NCT03620981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03620981

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
NCT number: NCT03620981
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 410 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Agitation Associated With Dementia of the Alzheimer's Type
Interventions: Brexpiprazole, Placebo
First posted: 2018-08-08
Last updated: 2024-11-14
Results first posted: 2024-11-14

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.	Baseline and 10 weeks first dose, on average 10 weeks	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	Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing.	Baseline and 10 weeks first dose, on average 10 weeks	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 10 Weeks After Dosing.	Baseline and 10 weeks first dose, on average 10 weeks	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

Outcomes3

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 Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.	Baseline and 10 weeks first dose, on average 10 weeks	The full analysis set (FAS) comprised subjects who, after randomization, 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 the treatment.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing.	Baseline and 10 weeks first dose, on average 10 weeks	Efficacy sample（FAS）consisted of all participants who have received at least 1 dose of the IMP and have Baseline and at least one Post-Baseline efficacy evaluation.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing.	Baseline and 10 weeks first dose, on average 10 weeks	Efficacy sample（FAS) consisted of all participants who have received at least 1 dose of the IMP and have Baseline and at least one Post-Baseline efficacy evaluation.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.	Brexpiprazole 1 mg	-11.7	Standard Error 1.20	units on a scale
Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.	Brexpiprazole 2 mg	-15.2	Standard Error 1.05	units on a scale
Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.	Placebo	-8.0	Standard Error 1.03	units on a scale
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing.	Brexpiprazole 1 mg	-1.0	Standard Error 0.1	units on a scale
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing.	Brexpiprazole 2 mg	-1.4	Standard Error 0.09	units on a scale
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing.	Placebo	-0.6	Standard Error 0.09	units on a scale
Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing.	Brexpiprazole 1 mg	3.1	Standard Deviation 1.3	units on a scale
Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing.	Brexpiprazole 2 mg	2.6	Standard Deviation 1.2	units on a scale
Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing.	Placebo	3.5	Standard Deviation 1.4	units on a scale

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Brexpiprazole 1 mg	112
Overall Study	STARTED	Brexpiprazole 2 mg	149
Overall Study	STARTED	Placebo	149
Overall Study	COMPLETED	Brexpiprazole 1 mg	83
Overall Study	COMPLETED	Brexpiprazole 2 mg	102
Overall Study	COMPLETED	Placebo	116
Overall Study	NOT COMPLETED	Brexpiprazole 1 mg	29
Overall Study	NOT COMPLETED	Brexpiprazole 2 mg	47
Overall Study	NOT COMPLETED	Placebo	33

Source ClinicalTrials.gov

Adverse events225

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
other	Constipation	Gastrointestinal disorders	Brexpiprazole 1 mg	5	112
other	Constipation	Gastrointestinal disorders	Brexpiprazole 2 mg	6	149
other	Constipation	Gastrointestinal disorders	Placebo	3	149
other	Diarrhoea	Gastrointestinal disorders	Brexpiprazole 1 mg	3	112
other	Diarrhoea	Gastrointestinal disorders	Brexpiprazole 2 mg	6	149
other	Diarrhoea	Gastrointestinal disorders	Placebo	8	149
other	Dysphagia	Gastrointestinal disorders	Brexpiprazole 1 mg	0	112
other	Dysphagia	Gastrointestinal disorders	Brexpiprazole 2 mg	4	149
other	Dysphagia	Gastrointestinal disorders	Placebo	0	149
other	Salivary hypersecretion	Gastrointestinal disorders	Brexpiprazole 1 mg	1	112

1 to 10 of 225Source ClinicalTrials.gov

See all 225 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Brexpiprazole 1 mg	2	112
Total, all-cause mortality	Brexpiprazole 2 mg	0	149
Total, all-cause mortality	Placebo	0	149
Total, other adverse events	Brexpiprazole 1 mg	77	112
Total, other adverse events	Brexpiprazole 2 mg	113	149
Total, other adverse events	Placebo	93	149
Total, serious adverse events	Brexpiprazole 1 mg	7	112
Total, serious adverse events	Brexpiprazole 2 mg	9	149
Total, serious adverse events	Placebo	7	149

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
40717666	DERIVED	PubMed
42847294	DERIVED	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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03620981

GET https://conductscience.org/api/trials/v1/NCT03620981/events?page=2

API reference For AI assistants