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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Brexpiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03594123

331-201-00182

Details and patient eligibility

About

Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type (AAD).

Enrollment: 259 patients

Sex: All

Ages: 55 to 91 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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259 participants in 2 patient groups

Prior Brexpiprazole

Experimental group

Description:

Participants who received brexpiprazole in a previous double-blind phase 3 study (Trial 331-14-213 {NCT03548584}), received the same dose of brexpiprazole \[2 or 3 milligrams (mg)\], once daily (QD), orally, as they received during the previous study, for up to 12 weeks with dose adjustment.

Treatment:

Drug: Brexpiprazole

Drug: Brexpiprazole

Prior Placebo

Experimental group

Description:

Participants who received placebo in a previous double-blind phase 3 study (Trial 331-14-213 {NCT03548584}), received brexpiprazole following a titration schedule, to gradually increase their dose from 0.5 mg QD, in the starting to 2 or 3 mg QD, orally, for up to 12 weeks with dose adjustment.

Treatment:

Drug: Brexpiprazole

Drug: Brexpiprazole