The following article is part of conference coverage from the American Academy of Neurology (AAN) 2021 Virtual Annual Meeting. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from the AAN 2021 Virtual Annual Meeting.
Treatment with pimavanserin does not adversely impact cognitive outcomes in patients with neurodegenerative disease, according to study results to be presented at the American Academy of Neurology 2021 Virtual Annual Meeting, to be held from April 17 to 22, 2021.
While neuropsychiatric symptoms are associated with worse outcomes in patients with dementia, there are no approved treatment options in the United States for dementia-related psychosis. The objective of the current study was to determine the impact of pimavanserin on cognitive function in patients with neuropsychiatric manifestations of neurodegenerative disease.
Study researchers collected data on 697 pimavanserin-treated patients with neuropsychiatric manifestations of neurodegenerative disease from 3 placebo-controlled clinical studies (019, 032, 046) that compared pimavanserin 34 mg with placebo, and from the phase 3 randomized-withdrawal study, HARMONY (ClinicalTrials.gov Identifier: NCT03325556), which included a 12-week open label phase followed by randomized double-blind period.
At week 12, the Mini-Mental State Examination score least squares mean change from baseline was -0.25 in 019, 0.0 in 032, and 1.2 in HARMONY. In the 046 interim analysis, the least squares mean change to week 8 was 1.2 with pimavanserin, compared with 0.5 with placebo.
During the double-blind period of the HARMONY trial, mean Mini-Mental State Examination score with pimavanserin did not decline and was similar to placebo. A total of 46 patients were treated with pimavanserin for the 9-month study duration and the mean change from baseline was 1.2.
Cognition-related treatment-emergent adverse events included state of confusion and memory impairment. These adverse events were not common and occurred at rates similar to placebo.
“Overall, pimavanserin did not have a negative impact on cognitive function with up to 9 months of treatment,” the study researchers concluded.
Ballard C, Foff EP, Tariot P, et al. Impact of pimavanserin on cognitive measures in patients with neurodegenerative disease(NDD): results from 4 placebo-controlled clinical studies. Presented at: American Academy of Neurology 2021 Virtual Annual Meeting; April 17-22, 2021. Abstract P1.012.