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) in patients with agitation associated with dementia of the Alzheimer's type

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224118

Enrollment

157

Registered

2018-10-29

Start date

2018-11-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation Associated With Dementia of the Alzheimer's Type

Interventions

investigational material(s) Generic name etc : Brexpiprazole INN of investigational material : - Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational mater

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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. 2. Patients whose caregiver can properly collect the necessary information.

Exclusion criteria

Exclusion criteria: 1. 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. 2. Patients who had delirium during the double-blind trial.

Design outcomes

Primary

Measure	Time frame
safety Adverse event, clinical laboratory tests, 12-lead ECGs, vital signs, body weight, physical examinations, pregnancy tests, DIEPSS, AIMS, BARS, S-STS	—

Secondary

Measure	Time frame
efficacy CMAI, CGI-S, CGI-I, NPI/NPI-NH	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026