Treatment for PD Psychosis Shows No Negative Effect on Motor, Cognitive Symptoms

Pimavanserin does not worsen motor- or cognition-related function in patients with Parkinson disease (PD) psychosis, suggest study findings published in Frontiers in Neurology.

“Pimavanserin, a selective serotonin (5-HT_2A) antagonist/inverse agonist, is the only treatment approved by the US Food and Drug Administration for hallucinations and delusions associated with PD psychosis,” wrote researchers. “This approval was based on data from clinical trials indicating improvement across select PD psychosis measures.”

To provide a fuller picture of the effect of pimavanserin in patients with PD psychosis, researchers analyzed safety data for motor- and cognition-related function as well as adverse events of interest from 4 placebo-controlled trials of pimavanserin 34 mg in the patient population.

The study included a pooled analysis spanned three 6-week studies (ACP-103-012, ACP-103-014, and ACP-103-020) and a subgroup of patients from HARMONY, a randomized discontinuation trial that included a 12-week open-label period followed by a randomized double-blind period that lasted up to 26 weeks.

Pimavanserin was well-tolerated in patients with PD psychosis, according to the analysis, including patients with PD dementia with psychosis. Compared with placebo, pimavanserin 34 mg had no negative effect on Unified Parkinson’s Disease Rating Scale (UPDRS) II + III, Extra-Pyramidal Symptom Rating Scale, or Mini-Mental State Examination scores.

Analysis from the HARMONY study identified no negative effect on motor or cognition-related-function over as many as 9 months of treatment, although researchers noted the finding was limited by the small sample size.

Rates of motor- and cognition-related adverse events were similar between patients treated with pimavanserin and those treated with placebo, study authors found.

“Treatment for PD psychosis should manage hallucinations and delusions without exacerbating underlying Parkinsonism, impairing cognition, or increasing the risk for sedation or other adverse events that currently limit the use of antipsychotics,” wrote researchers. “Overall, based on the collective data from 4 trials, pimavanserin was well tolerated and did not yield a negative impact on motor- or cognition-related function in elderly patients with PD psychosis.”

Reference:
Abler V, Brain C, Ballard C, Berrio A, Coate B, Espay AJ. Motor- and cognition-related safety of pimavanserin in patients with Parkinson’s disease psychosis. Front Neurol. Published online October 5, 2022. doi: 10.3389/fneur.2022.919778