Nuplazid Safety and Efficacy As Treatment for Neuropsychiatric Symptoms in Frail Older Adults with Neurodegenerative Disease Reported

Results from a 52-week, multicenter, phase 3b, open-label extension study (NCT03623321) revealed that Nuplazid (pimavanserin; Acadia Pharmaceuticals, San Diego, CA) was effective and generally safe as a treatment for neuropsychiatric symptoms in frail older adults with neurodegenerative disease. Nuplazid is approved by the Food and Drug Administration (FDA) to treat hallucinations and delusions associated with Parkinson disease (PD) with or without dementia.

Researchers recruited 595 participants (mean age 72.2 years) from a previous double-blind study of Nuplazid (NCT03575052); 95.3% of participants had a diagnosed dementia, including Alzheimer disease (AD; 68.7%), vascular dementia (18.5%), and PD (4.7%). Both the Nuplazid and placebo groups of the antecedent study received Nuplazid in the open-label study. 

The results, presented at the 2024 International Congress of Parkinson’s Disease and Movement Disorders, found that 40% of patients taking Nuplazid experienced TEAEs, with serious TEAEs occurring in 6.2% of patients and TEAEs leading to study discontinuation in 6.6%. Eleven patients (1.8%) taking Nuplazid experienced a TEAE leading to death. No significant difference in the rate of TEAEs between the Nuplazid and placebo groups of the previous study was observed.

Researchers also found no clinical impairment in those taking Nuplazid versus those taking placebo when testing for cognitive (Mini-Mental State Examination, MMSE) and motor function (Extrapyramidal Symptom Rating Scale-Abbreviated, ESRS-A).