The multicentre, randomised, double-blind, placebo-controlled, fixed-dose trial evaluated the efficacy, safety, and tolerability of two fixed doses of brexpiprazole that include 2mg per day or 3mg a day.
It included 345 participants aged 55 to 90 years (inclusive), who are with a diagnosis of probable Alzheimer’s disease.
It involved a continuous, 12-week double-blind treatment period with follow-up for 30 days.
The findings from the study showed that the patients who have received treatment with brexpiprazole had a statistically significant reduction in agitation compared to placebo.
The Cohen-Mansfield Agitation Inventory (CMAI) total score in participants receiving brexpiprazole was statistically higher compared to those in the placebo group.
A statistically superior improvement of Severity of Illness (CGI-S) score, as related to symptoms of agitation was also observed.
Headache was the only treatment-emergent adverse event (TEAE) observed in patients treated with brexpiprazole.
Otsuka Pharmaceutical said in a statement: “Brexpiprazole was generally well tolerated, and no new safety signals were observed.
“The following TEAEs occurred at an incidence of at least 2% in the brexpiprazole treatment group and greater than that of placebo: somnolence, nasopharyngitis, dizziness, diarrhea, urinary tract infection, and asthenia.”
The companies will further analyse the data set for determining the complete potential of brexpiprazole to treat agitation in Alzheimer’s dementia patients.
Later this year, they are also planning for a regulatory filing to the FDA using the results from the Phase III clinical trial.
The regulator granted Fast Track designation to speed up the review of brexpiprazole, in February 2016.