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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Agitation Associated With Dementia of the Alzheimer's Type

Treatments: Drug: Brexpiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03724942

JapicCTI-184179 (Other Identifier)

331-102-00184

Details and patient eligibility

About

To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy of brexpiprazole.

Enrollment: 164 patients

Sex: All

Ages: 55 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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164 participants in 1 patient group

Brexpiprazole

Experimental group

Treatment:

Drug: Brexpiprazole