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

Phase 3 Completed 164 enrolled Otsuka Pharmaceutical Co., Ltd.

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2018-11-09
Primary completion: 2021-12-02
Completion: 2022-01-05

Publications

Nakamura Y, Adachi J, Hirota N, Iba K, Shimizu K, Nakai M, Mori N, Takahashi K. Long-term safety and tolerability of brexpiprazole for Japanese patients with agitation in Alzheimer's disease dementia: A multicenter, open-label study. J Alzheimers Dis Rep. 2025 Apr 16;9:25424823251334054. doi: 10.1177/25424823251334054. eCollection 2025 Jan-Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brexpiprazole	Small molecule	1 mg	Oral
Subject	Brexpiprazole	Small molecule	2 mg	Oral

Indications

No indication recorded.