MedicalResearch.com Interview with: Gus Alva, MD, DFAPA Medical Director, ATP Clinical Research Medical Director, Senior Brain Health, Hoag Hospital, Newport Beach, Assistant Professor, Department of Psychiatry and Neuroscience University of California, Riverside, CA MedicalResearch.com: What is the background for this study? Response: This trial evaluated the effects of pimavanserin compared to placebo in frail older adults and elderly patients with neuropsychiatric symptoms related to Neurodegenerative disorder (NDD), such as hallucinations and delusions, to better understand the safety of pimavanserin in this population. The study was a phase 3b, 8-week treatment (study duration of up to 16 weeks) with the primary endpoint being safety and tolerability, measured by treatment-emergent adverse events (TEAEs). Secondary safety endpoints were change from baseline in motor and cognitive function; exploratory endpoints included suicidality, sleep quality, and neuropsychiatric symptoms. The reason for doing this study is that there is a high degree of interest in further understanding the safety of pimavanserin, as many antipsychotics used off label often have significant and serious adverse effects, including risk of falls, parkinsonism, and death. (more…)