Mixed Results With PD Drug in Alzheimer's Psychosis

Results of a phase II trial published in Lancet Neurology found oral pimavanserin only had short-term effectiveness in treating Alzheimer's psychosis, reports MedPage Today . The drug reached the peak of its effectiveness at six weeks of treatment compared to a placebo, but neither cohorts exhibited significant treatment differences after 12 weeks. The trial's findings "cannot be considered to be positive or clinically meaningful," says the University of Southern California in Los Angeles' Lon S. Schneider. He implies that the "significance of the primary outcome was driven by a worsening of the placebo-treated group at six weeks that was not observed at four weeks of treatment or at nine and 12 weeks of treatment." Pimavanserin received FDA approval in 2016 for the treatment of delusions and hallucinations caused by Parkinson's psychosis. There are currently no approved treatments specifically for psychosis in individuals with Alzheimer's. In the trial were 181 adults about 50 years old from more than 100 U.K. nursing communities. Ninety participants received two tablets of 17-mg pimavanserin daily, and were compared with 91 individuals who got the placebo. "The designation of a primary efficacy outcome at six weeks while continuing double-blind treatment for 12 weeks allowed assessment for a continuing effect over 12 weeks, and is a unique feature of this trial," Schneider says. "If the primary outcome had been specified for 12 weeks, typical of previous trials with antipsychotics, then pimavanserin would have been considered as not effective."