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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223994

Enrollment

407

Registered

2018-08-06

Start date

2018-08-20

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 (1mg,2mg) INN of investigational material : Brexpiprazole Therapeutic category code : 117 Psychotropic agents Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who satisfy both of the following diagnostic criteria: - Diagnosis of "Dementia due to Alzheimer's Disease" according to DSM-5. - Diagnosis of "Probable Alzheimer's Disease" according to NINCDS-ADRDA. 2. Hospitalized patients or care facility patients or care at home patients 3. Patients with an MMSE score of 1 to 22 4. Patients who have the agitation defind according to the "Consensus provisional definition of agitation in cognitive disorders" from the International Psychogeriatric Association (IPA)

Exclusion criteria

Exclusion criteria: 1. Patients who have dementia other than dementia of the Alzheimer's type 2. Patients diagnosed with delirium between 30 days before the screening examination and baseline evaluation according to DSM-5. 3. 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

Design outcomes

Primary

Measure	Time frame
efficacy Cohen-Mansfield Agitation Inventory(CMAI) Change from baseline at 10 weeks	—

Secondary

Measure	Time frame
efficacy Clinical Global Impression-Severity of Illness(CGI-S), Clinical Global Impression-Global Improvement(CGI-I) Change from baseline(CGI-S) at 10 weeks,score at10 weeks(CGI-I)	—

Countries

Japan

Outcome results

None listed

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