CompletedPhase 3Results posted

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

A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Safety of Extended Treatment With Brexpiprazole (OPC-34712) to Patients With Agitation Associated With Dementia of the Alzheimer's Type

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Asset

Brexpiprazole

Listed sites

Recruiting sites

Enrollment

164

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 55-89

Primary endpoint

•Subjects With Treatment-Emergent Adverse Events (TEAEs)

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 ID331-102-00184

Secondary IDJapicCTI-184179Japic

NCT IDNCT03724942

Timeline

Milestones

Study first posted2018-10-30actual

Study start2018-11-09actual

Primary completion2021-12-02actual

Study completion2022-01-05actual

Last update posted2024-09-19actual

Results first posted2024-09-19actual

Assets

Drug assets

Brexpiprazole

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age89 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at Week 10 of the double-blind trial.

•Patients whose caregiver can properly collect the necessary information

Exclusion criteria

•Patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial.

•Patients who had delirium during the double-blind trial.

Endpoints (8)

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

Safety / tolerability / PK

Other clinical outcomes

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 Weeks After Dosing

Time frame:Baseline and 14 weeks after dosing

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 Weeks After Dosing.

Time frame:Baseline and 14 weeks after dosing.

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 Weeks After Dosing

Time frame:Baseline and 14 weeks after dosing

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
ROLLOVER BREXn=96 Participants	-2.5	9.9
ROLLOVER PLACEBOn=60 Participants	-6.4	9.3

Secondary/registry result

Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 Weeks After Dosing.

Time frame:Baseline and 14 weeks after dosing.

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
ROLLOVER BREXn=96 Participants	-0.2	0.8
ROLLOVER PLACEBOn=60 Participants	-0.4	1.1

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs)

Time frame:From baseline to week 14

event count, event

Primary/registry result

The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs)

Time frame:From baseline to week 14

event count, event

Posted result

Group	Value (number), Percentage of percipitante	Reported bounds
ROLLOVER BREXn=102 Participants	90.2	-
ROLLOVER PLACEBOn=62 Participants	90.3	-

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Clinical Global Impression of Improvement (CGI-I) Score at 14 Weeks After Dosing

Time frame:14 weeks after dosing.

descriptive

Secondary/registry result

Clinical Global Impression of Improvement (CGI-I) Score at 14 Weeks After Dosing

Time frame:14 weeks after dosing.

descriptive

Posted result

Group	Value (mean), Units on a scale	Standard deviation
ROLLOVER BREXn=96 Participants	3.1	1.2
ROLLOVER PLACEBOn=60 Participants	2.7	1.1

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, Shimizu K, Nakai M, Mori N, Takahashi K. Long-term safety and tolerability of brexpiprazole for Japanese patients with agitation in Alzheimer's disease dementia: A multicenter, open-label study. J Alzheimers Dis Rep. 2025 Apr 16;9:25424823251334054. doi: 10.1177/25424823251334054. eCollection 2025 Jan-Dec.
PMID40290781via 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.