Antipsychotic Effective for Short-Term Use in Alzheimer Psychosis
Six-week treatment with pimavanserin is safe and effective vs placebo in patients with Alzheimer disease psychosis, according to new study findings. However, 12-week treatment with pimavanserin demonstrated no significant advantage over placebo.
For their study, the researchers assessed 345 nursing home residents aged 50 years or older with possible or probable Alzheimer disease and psychotic symptoms, including visual or auditory hallucinations, delusions, or both.
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A total of 181 participants were randomly assigned to receive two 17 mg/day oral pimavanserin tablets (n = 90) or placebo (n = 91) for 12 weeks. Of these 181, 178 were included in the modified intention-to-treat population. They were categorized based on baseline Mini-Mental State Examination total scores and Neuropsychiatric Inventory-Nursing Home version (NPI-NH) psychosis scores.
At baseline, mean total NPI-NH psychosis scores were 9.5 for pimavanserin recipients and 10.0 for placebo recipients. Results of the trial indicated that NPI-NH psychosis scores had improved at week 6 for pimavanserin vs placebo, with mean changes of -3.76 for pimavanserin and -1.93 for placebo. However, at week 12, no significant advantage was observed for pimavansderin over placebo (treatment difference -0.51)
Common adverse events included falls, urinary tract infections, and agitation. A total of 8 pimavanserin recipients and 11 placebo recipients discontinued treatment due to adverse events. The researchers noted that no detrimental effects on cognition or motor function were observed in either group.
“Pimavanserin showed efficacy in patients with Alzheimer's disease psychosis at the primary endpoint (week 6) with an acceptable tolerability profile and without negative effect on cognition,” the researchers concluded. “Further follow-up to week 12 did not show significant advantage for pimavanserin versus placebo.”
—Christina Vogt
Reference:
Ballard C, Banister C, Khan Z, et al. Evaluation of the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer's disease psychosis: a phase 2, randomized, placebo-controlled, double-blind study. Lancet Neurol. 2018;17(3):213-222. https://doi.org/10.1016/S1474-4422(18)30039-5.