On 13 February, the global healthcare company Otsuka Pharmaceutical, annouced topline results of its phase III clinical trial of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer’s disease (AD). The trial, known as 17-AVP-786-305, is a multicenter, randomised, double-blind and placebo-controlled study evaluating the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in people with dementia of the Alzheimer's type. More than 600 participants were enrolled in US and Europe and received either AVP-786 (low or high dose) or placebo orally twice-daily during 12 weeks.
The experimental drug failed to meet the primary efficacy endpoint of the study, which is the change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score between AVP-786 and placebo. During the trial, the incidence of falls was higher in participants receiving AVP-786, with 8.6% in the high dose group and 9.1% in the low dose group, compared to 2.8% in the placebo group. The company said there were four deaths reported in the trial, including one in the low dose group and three in the placebo group. The full study results are not yet available. The company is planning to analyse the full data to determine the potential of AVP-786 and intends to submit the trial results for scientific publication at a later date.
https://www.otsuka.co.jp/en/company/newsreleases/2024/20240213_1.html