Objective: Evaluate motor- and cognition-related safety in pimavanserin-treated patients with PDP.
Background: Pimavanserin, a selective 5-HT2A inverse agonist/antagonist, is the only US FDA-approved treatment for hallucinations and delusions associated with PDP.
Method: This analysis included PDP patients treated with pimavanserin 34 mg from a pooled dataset of 3 randomized, double-blind, placebo-controlled, 6-week studies (N=433 [pimavanserin, 202; placebo, 231]), and a subgroup of PD dementia (PDD) patients from HARMONY, a randomized discontinuation study, which included a 12-week open-label (OL) period (N=49) followed by a randomized double-blind (DB) period of up to 26 weeks (pimavanserin, n=16; placebo, n=20). Motor function was evaluated using the Unified Parkinson’s Disease Rating Scale Parts II + III (UPDRS) for PDP or the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) for PDD. Cognitive function was evaluated using the Mini-Mental State Examination (MMSE) in HARMONY.
Results: Baseline MMSE score ranged from 18–30 (PDP pooled) and 8–27 (HARMONY PDD). In the pooled analysis, least squares mean (LSM) (standard error [SE]) change from baseline (CFB) to week 6 for UPDRS II + III score was similar for pimavanserin (-2.4 [0.69]) and placebo (-2.3 [0.60]). CFB to week 6 for UPDRS II and UPDRS III scores were similar between groups. In HARMONY, OL mean (SE) CFB to week 12 (n=39) ESRS-A score was -1.7 (0.74). DB mean (SE) CFB to week 26 ESRS-A score was similar between pimavanserin (n=4, 1.0 [2.68]) and placebo (n=2, 0.5 [1.50]). MMSE score mean (SE) CFB was 0.3 (0.66) at OL week 12 (n=37) and was comparable between pimavanserin- and placebo-treated patients at DB week 26 (pimavanserin [n=4], 0.8 [0.75]; placebo [n=2], 0.5 [2.50]). Rates of motor-related and cognition-related adverse events were balanced between pimavanserin and placebo in both analyses.
Conclusion: Pimavanserin 34 mg was well tolerated and did not yield a negative impact on motor-related or cognition-related function in PDP patients.
To cite this abstract in AMA style:
V. Abler, C. Ballard, A. Berrio, B. Coate, C. Brain, A. Espay. Motor-Related and Cognition-Related Safety of Pimavanserin in Patients with Parkinson’s Disease Psychosis (PDP) [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/motor-related-and-cognition-related-safety-of-pimavanserin-in-patients-with-parkinsons-disease-psychosis-pdp/. Accessed June 14, 2025.« Back to 2022 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/motor-related-and-cognition-related-safety-of-pimavanserin-in-patients-with-parkinsons-disease-psychosis-pdp/