On 13 April, Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced the decision to continue the recruitment of research participants in the Phase III clinical trial evaluating brexpiprazole for the treatment of agitation in people with dementia of the Alzheimer's type. This decision is based on the results of an independent interim analysis.
This 12-week Phase III study is a multicenter, randomised, double-blind and placebo-controlled study evaluating the efficacy, safety, and tolerability of two doses of brexpiprazole compared with placebo. Sponsors are planning to recruit 330 participants between 55 and 90 years old with agitation associated with dementia of the Alzheimer's type. Completion of the trial is expected in the first half of 2022. As agreed with the US Food and Drug Administration (FDA), an interim analysis conducted was planned when 255 participants had completed the trial.
