Real-world neuropsychiatric safety profile of foslevodopa/foscarbidopa infusion in advanced Parkinson's disease.

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BackgroundTo describe demographic, clinical, and neuropsychiatric safety outcomes in a cohort of PD patients treated with LDp/CDp infusion in a real-world setting.MethodsWe retrospectively analyzed a database of 77 consecutive PD patients treated with LDp/CDp at two Italian tertiary referral centers, with a minimum 6-month follow-up. Baseline cognitive, epidemiological, and clinical variables were assessed to determine potential neuropsychiatric adverse event (NAE) risk factors.ResultsPatients had long disease duration (13.8±6.4 years) and moderate-to-severe motor burden (MDS-UPDRS III: 34.4±15). Pre-existing cognitive impairment (MCI 41.6%, dementia 7.8%), prior hallucinations (26%), and impulse control disorders (27.3%) were frequent. At 6 months, mean L-dopa equivalent daily dose increased by ~300 mg (pConclusionsLDp/CDp infusion is well-tolerated. Although NAEs were more frequent than in pivotal trials, they were largely manageable. Frontal executive dysfunction emerged as a significant risk factor, suggesting specific frontal screening should be routine in candidacy evaluation for cognitively frail patients. Preventive strategies to reduce risk are proposed and discussed.

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