Pimavanserin 34 mg was safe and effective in reducing the risk of psychosis relapse in patients with Parkinson disease dementia (PDD), according to results presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, held from April 2 to April 7 in Seattle, Washington, and virtually from April 24-26, 2022.
In the US, pimavanserin has been approved to treat hallucinations and delusions associated with PDP. The drug has been studied to treat dementia-related psychosis, including patients with PDD in a HARMONYA trial. The objective of the current study was to determine whether pimavanserin 34 mg is safe and effective in treating hallucinations and delusions in patients with PDD from in the HARMONY trial.
In a phase 3, placebo-controlled, randomized discontinuation trial (HARMONY; Clinical Trials.gov Identifier: NCT03325556), patients were administered pimavanserin for 12 weeks (N=392). Patients who had a sustained response at weeks 8 and 12 were randomized 1:1 to continue pimavanserin or receive a placebo for up to 26 weeks during the double-blind (DB) period with the primary endpoint being time from randomization to psychosis relapse. In order to ascertain cognition and motor function, both the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) and the Mini-Mental State Examination (MMSE) were used.
A total of 59 enrollees had PDD and began pimavanserin 34 mg while 49 out of 59 patients continued to receive pimavanserin 34 mg. Most PDD patients (73.5% [36/49]) during the open-label period showed a sustained response and were randomized to receive pimavanserin (n=16) or placebo (n=20).
Those taking pimavanserin had a lower risk for psychosis relapse compared with enrollees administered the placebo (hazard ratio: 0.052; 95% CI: 0.016, 0.166; 1-sided P <0.0001). A total of 9 patients who were administered a placebo and 1 patient treated with pimavanserin met the relapse criteria.
A total of 23 enrollees (46%) experienced a treatment-emergent adverse event (TEAE) during the open-label period, while in the double-blind period TEAE rates were balanced (pimavanserin, 31.3% [n=5], placebo, 45.0% [n=9]). Throughout the study, pimavanserin did not have negative effects on ESRS-A or MMSE scores.
The study authors concluded that “Pimavanserin 34 mg reduced the risk for psychosis relapse in PDD patients. Pimavanserin was well tolerated, with no negative effect on motor or cognitive function. These data show the maintenance of antipsychotic efficacy and safety of pimavanserin in PDD patients.”
Weintraub D, Espay A, Sharma V. Pimavanserin treatment of hallucinations and delusions in patients with Parkinson’s disease dementia: post hoc analysis of the HARMONY trial. Presented at: the 2022 AAN Annual Meeting; April 2-7, 2022; Seattle, Washington; April 24-26, 2022; Virtual Meeting.
This article originally appeared on Neurology Advisor