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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-11

Study Completion Date

2022-09-19

Brief Summary

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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).

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prior Brexpiprazole

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.

Group Type EXPERIMENTAL

Brexpiprazole

Intervention Type DRUG

2 or 3 mg tablet

Prior Placebo

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.

Group Type EXPERIMENTAL

Brexpiprazole

Intervention Type DRUG

0.5 to 3 mg tablet

Interventions

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Brexpiprazole

2 or 3 mg tablet

Intervention Type DRUG

Brexpiprazole

0.5 to 3 mg tablet

Intervention Type DRUG

Eligibility Criteria

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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.