Pimavanserin does not worsen motor function in patients with neurodegenerative disease

Conference

AAN 2021

Trial

HARMONY, 019, 046, 032

Pimavanserin did not have a negative impact on motor function in patients with neuropsychiatric symptoms of neurodegenerative disease [1]. This selective serotonin 5-HT2A receptor inverse agonist/antagonist did not seem to affect cognitive function either [2].

Psychosis and other neuropsychiatric symptoms are common among patients with dementia. Use of (off-label) antipsychotics in these patients is associated with significant adverse outcomes, including declining motor function and accelerated cognitive decline. The effect of pimavanserin on motor function changes was evaluated in 3 studies: 2 double-blind, parallel-group studies (019 [NCT02035553] & 046 [NCT03575052]) and the HARMONY randomised withdrawal study (NCT03325556). Patients had neuropsychiatric manifestations of neurodegenerative disease (n=626 receiving pimavanserin), including dementia-related psychosis (n=562 receiving pimavanserin). In all 3 studies, mean changes in motor function were minimal in pimavanserin-treated patients and similar to placebo. Motor-related treatment-emergent adverse events were reported at rates ≤2.2%, which was similar to placebo.

A review of 4 studies (adding 032 [NCT02992132] to the 3 mentioned above) evaluated the impact of up to 9 months of treatment with pimavanserin on cognitive measures in patients with neuropsychiatric manifestations of neurodegenerative disease. Cognitive function was measured by Mini-Mental State Examination (MMSE). Overall, pimavanserin did not have a negative impact on cognitive function in patients with neurodegenerative disease. Across all 4 studies, mean changes in MMSE score were small and similar to placebo. Confusion and memory impairment were the only cognition-related treatment-emergent adverse events reported. They were infrequent and occurred at rates similar to placebo.

Weintraub D. Motor function in patients with neuropsychiatric manifestations of neurodegenerative disease treated with pimavanserin. S19.005, AAN 2021 Virtual Congress, 17-22 April.
Ballard C. Impact of pimavanserin on cognitive measures in patients with neurodegenerative disease (NDD): results from 4 placebo-controlled clinical studies. P1.012, AAN 2021 Virtual Congress, 17-22 April.

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