Lundbeck and Otsuka announce decision to continue phase III clinical trial evaluating brexpiprazole for treatment of agitation in patients with Alzheimer’s-type dementia.
The decision to continue the trial is based on the results of an independent interim analysis, supporting to progress the trial to the planned full enrollment of 330 patients, announces the company in a press release.
Completion of the trial is expected in the first half of 2022.
About the study
Trial 331-14-213 was designed to assess the safety, tolerability and efficacy of brexpiprazole in the treatment of patients with agitation in Alzheimer’s dementia. The trial consists of a continuous 12-week double-blind treatment period with a 30-day follow-up. The trial population is planned to include 330 male and female patients, aged 55–90 years, with a diagnosis of probable Alzheimer’s disease.
The primary outcome is change in the Cohen-Mansfield Agitation Inventory (CMAI) Total score. The key secondary outcome measure is change in the Clinical Global Impression – Severity of Illness (CGI-S) score, as related to symptoms of agitation. Participating countries include Bulgaria, Hungary, Serbia, Slovakia, Spain, Ukraine and the U.S. Approximately half of the patients in the trial are living at home and the rest are institutionalized.
As agreed with the U.S. Food and Drug Administration (FDA), an interim analysis conducted by an independent Data Monitoring Committee was planned to assess both efficacy and futility, in accordance to pre-specified criteria, when 255 subjects had completed the trial.