CompletedPhase 3Results posted

A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

A 12-week, Multicenter, Active-treatment Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Asset

Brexpiprazole

Listed sites

Recruiting sites

Enrollment

259

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Treatment-emergent Adverse Events (TEAEs) by Severity

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 ID331-201-00182

NCT IDNCT03594123

Timeline

Milestones

Study first posted2018-07-20actual

Study start2018-10-11actual

Primary completion2022-09-19actual

Study completion2022-09-19actual

Last update posted2023-11-14actual

Results first posted2023-11-14actual

Assets

Drug assets

Brexpiprazole

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age91 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participants must have participated in the 331-14-213 study.

•Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior

Exclusion criteria

•Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.

Endpoints (2)

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.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity

Time frame:From first dose through 30 days after last dose of study drug (Up to approximately Week 16)

threshold achievement, event

Primary/registry result

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity

Time frame:From first dose through 30 days after last dose of study drug (Up to approximately Week 16)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	Reported bounds
Prior BrexpiprazoleMildn=163 Participants	20.9	-
Moderaten=163 Participants	9.2	-
Severen=163 Participants	3.1	-
Prior PlaceboMildn=96 Participants	13.5	-
Moderaten=96 Participants	19.8	-
Severen=96 Participants	0	-

Publications (4)

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

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.