In the phase III study, caregiver burden score improvements persisted for nine months before steadily worsening. Because CGI scores were stable or improved for two years, factors other than psychosis may influence the change in caregiver burden score, the researchers said.
Pimavanserin appears safe and well tolerated at doses as high as 60 mg in the open-label setting, the researchers said. The most common adverse events leading to discontinuation were hallucination (11 subjects, 2%), confusional state (six subjects, 1%), Parkinson’s disease (seven subjects, 1%), fall, psychotic disorder, myocardial infarction, and urinary tract infection (five subjects each, 1%). All other events leading to discontinuation occurred in less than 1% of subjects, the researchers said.
—Jake Remaly