Research & Development
Otsuka and Lundbeck announce decision to continue phase III clinical trial evaluating brexpiprazole for treatment of agitation in patients with Alzheimer's-type dementia
14 April 2021 -

Japan-based Otsuka Pharmaceutical Co Ltd (Otsuka) and Danish pharmaceutical company H. Lundbeck A/S (Lundbeck) announced on Tuesday the decision to continue the recruitment of patients in the phase III clinical trial of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type.

The decision to continue the trial is based on the results of an independent interim analysis, supporting the trial's progress to the planned full enrolment of 330 patients. The continuation of the study is intended to enable the companies to further explore the efficacy of brexpiprazole to address the high medical need in patients suffering from agitation in Alzheimer's type dementia.

The trial was designed to assess the safety, tolerability and efficacy of brexpiprazole in the treatment of dementia patients. The trial consisted of a 12-week double-blind treatment period with a 30-day follow-up. The primary outcome was the change in the CMAI total score. The key secondary outcome was the change in the Clinical Global Impression - Severity of Illness (CGI-S) score, as related to symptoms of agitation. As agreed with the FDA, an interim analysis conducted by an independent data monitoring committee assessed the efficacy on the CMAI total score, in accordance with pre-specified criteria when 255 subjects had completed the trial.

Completion of the trial is expected in the first half of 2022.