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CompletedPhase 2 / PHASE3Results posted

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

A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Asset

Brexpiprazole

Listed sites

Recruiting sites

Enrollment

410

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 1-22

Primary endpoint

•Cohen-Manfield Agitation Inventory(CMAI) Score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID331-102-00088

NCT IDNCT03620981

Timeline

Milestones

Study first posted2018-08-08actual

Study start2018-08-20actual

Primary completion2023-04-21actual

Study completion2023-05-15actual

Last update posted2024-11-14actual

Results first posted2024-11-14actual

Assets

Drug assets

Brexpiprazole

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients who satisfy both of the following diagnostic criteria:

1. Diagnosis of "Dementia due to Alzheimer's Disease" according to DSM-5.

2. Diagnosis of "Probable Alzheimer's Disease" according to NINCDS-ADRDA.

•Hospitalized patients or care facility patients or care at home patients

•Patients with an MMSE score of 1 to 22

•Patients who have the agitation defined according to the "Consensus provisional definition of agitation in cognitive disorders" from the International Psychogeriatric Association (IPA)

Exclusion criteria

•Patients who have dementia other than dementia of the Alzheimer's type

•Patients diagnosed with delirium between 30 days before the screening examination and baseline evaluation according to DSM-5.

•Patients diagnosed with any of the following disorders according to DSM-5:

-Schizophrenia spectrum and other psychotic disorders

-Bipolar and related disorders

-Major depressive disorder

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Other clinical outcomes

Behavior / neuropsychiatric

4 endpoints

Primary/protocol endpoint

Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.

Time frame:Baseline and 10 weeks first dose, on average 10 weeks

change from baseline, improvement

Primary/registry result

Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.

Time frame:Baseline and 10 weeks first dose, on average 10 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Brexpiprazole 1 mgn=108 Participants	-11.7	1.20
Brexpiprazole 2 mgn=148 Participants	-15.2	1.05
Placebon=147 Participants	-8.0	1.03

LS Mean Difference (Final Values)-7.295% CI-10.0 - -4.3p< 0.0001Mixed Models Analysis

Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.

LS Mean Difference (Final Values)-3.795% CI-6.8 - -0.7p0.0175Mixed Models Analysis

Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.

Secondary/protocol endpoint

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing.

Time frame:Baseline and 10 weeks first dose, on average 10 weeks

change from baseline, improvement

Secondary/registry result

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing.

Time frame:Baseline and 10 weeks first dose, on average 10 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Brexpiprazole 1 mgn=108 Participants	-1.0	0.1
Brexpiprazole 2 mgn=148 Participants	-1.4	0.09
Placebon=147 Participants	-0.6	0.09

LS Mean Difference (Final Values)-0.895% CI-1.0 - -0.5p< 0.0001Mixed Models Analysis

Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.

LS Mean Difference (Final Values)-0.395% CI-0.6 - -0.1p0.0083Mixed Models Analysis

Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing.

Time frame:Baseline and 10 weeks first dose, on average 10 weeks

descriptive

Secondary/registry result

Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing.

Time frame:Baseline and 10 weeks first dose, on average 10 weeks

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Brexpiprazole 1 mgn=108 Participants	3.1	1.3
Brexpiprazole 2 mgn=148 Participants	2.6	1.2
Placebon=147 Participants	3.5	1.4

Mean Difference (Final Values)-0.995% CI-1.2 - -0.6p< 0.0001Cochran-Mantel-Haenszel

Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.

Mean Difference (Final Values)-0.595% CI-0.8 - -0.1p0.0052Cochran-Mantel-Haenszel

Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Nakamura Y, Adachi J, Hirota N, Iba K, Sasajima C, Shimizu K, Nakai M, Takahashi K. Brexpiprazole's impacts on patients and caregivers in agitation in Alzheimer's dementia. Alzheimers Dement. 2025 Jul;21(7):e70522. doi: 10.1002/alz.70522.
PMID40717666via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.