Axovant is currently conducting a phase 2, multi-center, double-blind, placebo-controlled crossover study evaluating nelotanserin in patients with Lewy body dementia (LBD) suffering from visual hallucinations.
The safety, efficacy and tolerability of nelotanserin at doses of 40 mg and 80 mg will be evaluated over a 4-week treatment period in approximately 20 subjects with LBD. This is a crossover study so every subject will receive placebo for 4 weeks and nelotanserin for 4 weeks but neither patients or their doctor will know which treatment they are taking. The primary outcome measure will be safety and tolerability. The frequency and severity of visual hallucinations over a 4-week treatment period will be a secondary outcome measure. Patients who complete the study will be eligible to receive nelotanserin in an extension study.