Trial reportBMC neurology2025
Safety and efficacy of pimavanserin in patients with Lewy body dementia experiencing dementia-related psychosis in the HARMONY study.
Trial report in BMC neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03325556 (A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPimavanserin is approved by the US Food and Drug Administration for the treatment of hallucinations and delusions associated with Parkinson's disease. We analyzed the effect of pimavanserin on psychosis in patients with Lewy body dementia, including Parkinson's disease dementia (PDD) and dementia with Lewy bodies (DLB), from the phase 3 HARMONY trial.
methodsThis subgroup analysis included patients with PDD or DLB from HARMONY, a previously completed, multicenter, randomized, discontinuation study of pimavanserin for dementia-related psychosis. Patients with moderate to severe psychosis received pimavanserin 34 mg once daily for 12 weeks (open-label treatment). Those who achieved a sustained response at weeks 8 and 12 were randomized to continue treatment with pimavanserin or discontinue treatment and receive placebo for up to 26 weeks in the double-blind period. The primary endpoint was the time to psychosis relapse as defined by prespecified criteria. Safety was evaluated by adverse events; effects on motor symptoms and cognitive abilities were also assessed.
resultsOverall, 392 patients were enrolled in HARMONY; 49 patients with PDD and 27 patients with DLB were included in the open-label safety analysis, of whom 46 met response criteria and were randomized to receive pimavanserin (n = 22) or placebo (n = 24) during the double-blind period. Psychosis relapse risk was significantly lower with pimavanserin vs. placebo (hazard ratio, 0.031; 95% CI, 0.010-0.103; 2-sided nominal P < 0.0001). Fewer than 50% of patients experienced an adverse event in either treatment period; pimavanserin did not negatively affect motor or cognitive function.
conclusionsPsychosis relapse risk was significantly lower with pimavanserin vs. placebo in patients with Lewy body dementia. Pimavanserin was also well tolerated and did not worsen motor or cognitive function. Results should be interpreted cautiously since this study is a post hoc analysis of a previous trial that was not originally designed or powered to draw clinical conclusions based on dementia subgroups.
trial registrationClinicalTrials.gov Identifier: NCT03325556 (registered 18 October 2017).
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