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

Summary

To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the safety of brexpiprazole and identify the optimum dose.

Timeline

Start

2018-08-20

Primary completion

2023-04-21

Completion

2023-05-15

Outcome

Met primary endpoint

registry analysis (superiority test); Brexpiprazole 2 mg vs Placebo; p < 0.0001; LS Mean Difference (Final Values) -7.2 (95% CI -10.0 to -4.3); Mixed Models Analysis NCT03620981 ↗

registry analysis (superiority test); Brexpiprazole 1 mg vs Placebo; p = 0.0175; LS Mean Difference (Final Values) -3.7 (95% CI -6.8 to -0.7); Mixed Models Analysis NCT03620981 ↗

Publications

• Nakamura Y, Adachi J, Hirota N, Iba K, Sasajima C, Shimizu K, Nakai M, Takahashi K. Brexpiprazole's impacts on patients and caregivers in agitation in Alzheimer's dementia. Alzheimers Dement. 2025 Jul;21(7):e70522. doi: 10.1002/alz.70522.

Drugs

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

Indications

No indication recorded.