Long-term safety and tolerability of brexpiprazole for Japanese patients with agitation in Alzheimer's disease dementia: A multicenter, open-label study.

ABSTRACT:

Background

The long-term safety and efficacy of brexpiprazole in Asian patients with agitation associated with dementia due to Alzheimer's disease are unknown.

Objectives

To evaluate the safety of 14-week treatment with brexpiprazole 1 or 2 mg/day in Japanese patients who completed the 10-week double-blind treatment period in a parent phase 2/3 study, and to explore the efficacy of brexpiprazole.

Methods

This was a phase 3 multicenter, open-label study (ClinicalTrials.gov Identifier NCT03724942, registered on 28 October 2018). Patients who had completed 10-week treatment of placebo, 1 or 2 mg/day of brexpiprazole in a parent study were rolled over into this extended study. The primary endpoint was the frequency of adverse events.

Results

Of 183 patients with in

SUBMITTER: Nakamura Y 

PROVIDER: S-EPMC12033557 | biostudies-literature | 2025 Jan-Dec

REPOSITORIES: biostudies-literature