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- W2786029268 abstract "Background Pimavanserin is a selective 5-HT2A receptor inverse agonist and antagonist approved in the USA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. No safe or effective pharmacological treatment is approved for psychosis in patients with Alzheimer's disease. Therefore, we aimed to evaluate the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer's disease psychosis. Methods We did a phase 2, randomised, double-blind, placebo-controlled, single-centre (with multiple affiliated nursing home sites across the UK) study. We included participants of either sex who were aged 50 years or older with possible or probable Alzheimer's disease and psychotic symptoms including visual or auditory hallucinations, delusions, or both. Participants were randomly assigned (1:1) to 12 weeks of oral treatment with either pimavanserin (two 17 mg tablets daily) or placebo, with use of permuted block sizes of four and stratified by baseline Mini-Mental State Examination (MMSE) total score (<6 or ≥6) and Neuropsychiatric Inventory–Nursing Home version (NPI–NH) psychosis score (<12 or ≥12). Participants, caregivers, the study sponsor, and study personnel at the clinic site were masked to treatment assignment. The primary endpoint was mean change from baseline to week 6 in the NPI–NH psychosis score for pimavanserin versus placebo in the modified intention-to-treat population. Sustained benefit and safety of pimavanserin were assessed through week 12. This study is registered at ClinicalTrials.gov, number NCT02035553. Findings Between Jan 16, 2014, and Oct 27, 2016, 345 participants across 133 nursing homes were screened, of whom 181 were randomly assigned treatment (n=90 pimavanserin and n=91 placebo). 178 participants were included in the modified intention-to-treat population. Mean total baseline NPI–NH psychosis scores were 9·5 (SD 4·8) for the pimavanserin group and 10·0 (5·6) for the placebo group. Mean change in the NPI–NH psychosis score at week 6 was −3·76 points (SE 0·65) for pimavanserin and −1·93 points (0·63) for placebo (mean difference −1·84 [95% CI −3·64 to −0·04], Cohen's d=−0·32; p=0·045). By week 12, no significant advantage for pimavanserin versus placebo was observed for the overall study population (treatment difference −0·51 [95% CI −2·23 to 1·21]; p=0·561). Common adverse events were falls (21 [23%] of 90 participants in the pimavanserin group vs 21 [23%] of 91 in the placebo group), urinary tract infections (20 [22%] vs 25 [28%]), and agitation (19 [21%] vs 13 [14%]). Eight (9%) participants on pimavanserin and 11 (12%) on placebo discontinued treatment because of adverse events. No detrimental effect was observed on cognition or motor function in either group. Interpretation 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. Further follow-up to week 12 did not show significant advantage for pimavanserin versus placebo. Funding ACADIA Pharmaceuticals. Pimavanserin is a selective 5-HT2A receptor inverse agonist and antagonist approved in the USA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. No safe or effective pharmacological treatment is approved for psychosis in patients with Alzheimer's disease. Therefore, we aimed to evaluate the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer's disease psychosis. We did a phase 2, randomised, double-blind, placebo-controlled, single-centre (with multiple affiliated nursing home sites across the UK) study. We included participants of either sex who were aged 50 years or older with possible or probable Alzheimer's disease and psychotic symptoms including visual or auditory hallucinations, delusions, or both. Participants were randomly assigned (1:1) to 12 weeks of oral treatment with either pimavanserin (two 17 mg tablets daily) or placebo, with use of permuted block sizes of four and stratified by baseline Mini-Mental State Examination (MMSE) total score (<6 or ≥6) and Neuropsychiatric Inventory–Nursing Home version (NPI–NH) psychosis score (<12 or ≥12). Participants, caregivers, the study sponsor, and study personnel at the clinic site were masked to treatment assignment. The primary endpoint was mean change from baseline to week 6 in the NPI–NH psychosis score for pimavanserin versus placebo in the modified intention-to-treat population. Sustained benefit and safety of pimavanserin were assessed through week 12. This study is registered at ClinicalTrials.gov, number NCT02035553. Between Jan 16, 2014, and Oct 27, 2016, 345 participants across 133 nursing homes were screened, of whom 181 were randomly assigned treatment (n=90 pimavanserin and n=91 placebo). 178 participants were included in the modified intention-to-treat population. Mean total baseline NPI–NH psychosis scores were 9·5 (SD 4·8) for the pimavanserin group and 10·0 (5·6) for the placebo group. Mean change in the NPI–NH psychosis score at week 6 was −3·76 points (SE 0·65) for pimavanserin and −1·93 points (0·63) for placebo (mean difference −1·84 [95% CI −3·64 to −0·04], Cohen's d=−0·32; p=0·045). By week 12, no significant advantage for pimavanserin versus placebo was observed for the overall study population (treatment difference −0·51 [95% CI −2·23 to 1·21]; p=0·561). Common adverse events were falls (21 [23%] of 90 participants in the pimavanserin group vs 21 [23%] of 91 in the placebo group), urinary tract infections (20 [22%] vs 25 [28%]), and agitation (19 [21%] vs 13 [14%]). Eight (9%) participants on pimavanserin and 11 (12%) on placebo discontinued treatment because of adverse events. No detrimental effect was observed on cognition or motor function 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. Further follow-up to week 12 did not show significant advantage for pimavanserin versus placebo." @default.
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- W2786029268 title "Evaluation of the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer's disease psychosis: a phase 2, randomised, placebo-controlled, double-blind study" @default.
- W2786029268 cites W1164896577 @default.
- W2786029268 cites W1702828780 @default.
- W2786029268 cites W1785160854 @default.
- W2786029268 cites W1847168837 @default.
- W2786029268 cites W1867692464 @default.
- W2786029268 cites W1968565337 @default.
- W2786029268 cites W1981747359 @default.
- W2786029268 cites W1992109356 @default.
- W2786029268 cites W1996776294 @default.
- W2786029268 cites W2010166974 @default.
- W2786029268 cites W2014699979 @default.
- W2786029268 cites W2021809156 @default.
- W2786029268 cites W2055160638 @default.
- W2786029268 cites W2072303299 @default.
- W2786029268 cites W2074146160 @default.
- W2786029268 cites W2088317481 @default.
- W2786029268 cites W2091570747 @default.
- W2786029268 cites W2107881620 @default.
- W2786029268 cites W2111963393 @default.
- W2786029268 cites W2118050758 @default.
- W2786029268 cites W2126128851 @default.
- W2786029268 cites W2132592055 @default.
- W2786029268 cites W2132871355 @default.
- W2786029268 cites W2135939083 @default.
- W2786029268 cites W2142274632 @default.
- W2786029268 cites W2154596951 @default.
- W2786029268 cites W2156220037 @default.
- W2786029268 cites W2157331971 @default.
- W2786029268 cites W2162034231 @default.
- W2786029268 cites W2166643169 @default.
- W2786029268 cites W2322295935 @default.
- W2786029268 cites W2329441002 @default.
- W2786029268 cites W2333793022 @default.
- W2786029268 cites W2468352757 @default.
- W2786029268 cites W2473999118 @default.
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- W2786029268 doi "https://doi.org/10.1016/s1474-4422(18)30039-5" @default.
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