Alzheimer Hastalığı Psikozunda Pimavanserin: Daha Çok Duyulan Psikotik Semptomları Olan Hastalarda Etkinlik.

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BackgroundPimavanserin is a 5-HT2A receptor inverse agonist/antagonist and is approved in the United States for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.ObjectiveEvaluate the efficacy of pimavanserin on symptoms of psychosis in patients with Alzheimer's disease (AD).DesignRandomized, double-blind, placebo-controlled trial.SettingNursing home residents.ParticipantsPatients with AD psychosis.InterventionsPimavanserin 34 mg or placebo daily for 12 weeks.MeasurementsThe primary endpoint was mean change from baseline at Week 6 on the Neuropsychiatric Inventory-Nursing Home Version psychosis score (NPI-NH-PS). In the prespecified subgroup analysis, the mean change in NPI-NH-PS and the responder rates among those with baseline NPI-NH-PS ≥12 were evaluated.ResultsOf 181 patients randomized (n=90 pimavanserin; n=91 placebo), 57 had baseline NPI-NH-PS ≥12 (n=27 pimavanserin; n=30 placebo). In this severe subgroup, large treatment effects were observed (delta=-4.43, Cohen's d=-0.73, p=0.011), and ≥30% improvement was 88.9% vs. 43.3% (pConclusionsPimavanserin demonstrated significant efficacy in AD psychosis in patients with higher baseline severity of psychotic symptoms (NPI-NH-PS ≥12). Treatment with pimavanserin showed an acceptable tolerability profile.

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