Pimavanserin Reduces Delusions and Relapse Risk in Dementia-Related Psychosis

Treatment with pimavanserin in patients with dementia-related psychosis was found to be associated with significant reductions in relapse risk and treatment discontinuation compared with treatment with placebo, according to results from the HARMONY study presented at Psych Congress 2020, held virtually from September 10 to 13, 2020.

The HARMONY trial (ClinicalTrials.gov Identifier: NCT03325556) was a phase 3, relapse-prevention study of pimavanserin in patients with dementia-related psychosis. In this analysis of the HARMONY trial, open-label pimavanserin was administered to patients with moderate to severe psychosis associated with Parkinson disease, dementia with Lewy bodies, possible or probable Alzheimer disease, frontotemporal degeneration spectrum disorders, or vascular dementia.

A total of 217 eligible patients experienced a sustained response to therapy at weeks 8 and 12 and were randomly assigned to continue with pimavanserin (n=105) or placebo (n=112) for up to 26 weeks in the double-blind portion. The primary end point included time from randomization to relapse during the double-blind period.

Interim analysis found that pimavanserin was associated with a >2.8-fold reduction in risk of relapse compared with placebo (hazard ratio [HR], 0.353; 95% CI, 0.172-0.727; P =.0023), which resulted in early termination of the trial for superior efficacy. Treatment with pimavanserin was also associated with a 2.2-fold greater reduction in the risk of all-cause discontinuation compared with placebo (HR, 0.452; 95% CI, 0.261-0.785; P =.0024).

During the open-label period, approximately 36.2% of patients experienced adverse events; rates of adverse events were fairly similar between treatment and placebo groups in the randomized portion of the study (41.0% vs 36.6%, respectively). The HARMONY investigators did not observe any negative trends for worsening motor function or cognition as assessed by the Extrapyramidal Symptoms Rating Scale-A and the Mini-Mental State Examination, respectively.

Disclosure: This study was supported by Acadia Pharmaceuticals, Inc. Please see the original reference for a full list of authors’ disclosures.

Reference

Foff E, Cummings J, Soto-Martin M, et al. Pimavanserin significantly reduces risk of relapse of dementia-related psychosis: Results from the double-blind phase of the HARMONY study. Presented at: Psych Congress 2020 Virtual Experience; September 10-13, 2020. Poster 187.