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BackgroundParkinson's disease (PD) is a neurodegenerative disorder affecting both sexes, but differences exist between male and female in clinical manifestations, functional impact of symptoms and hormonal influences. Therefore, representativeness of females in PD trials indirectly determines the external validity of the clinical research in this field.ObjectiveTo estimate the representativeness of female in infusion therapy trials for advanced PD.MethodsPubMed and EMBASE databases were searched (1980 to September 2023), along with congress abstracts, to identify controlled clinical trials and large non-controlled studies on infusion therapies in PD enrolling >100 patients. Random-effect meta-analysis was conducted to estimate mean pooled prevalence of females included in the studies. Subgroup analyses were conducted accordingly to study design and intervention.ResultsWe included 15 studies (six studies on levodopa-carbidopa intestinal gel, six on subcutaneous levodopa, two on subcutaneous apomorphine, and one on levodopa-carbidopa-entacapone intestinal gel). Sex was not a randomisation stratification factor in any of these studies. Only one study explored differences in the outcome estimated according to sex. Overall, the proportion of female included was 38% (95% CI:33%-43%; I2 = 74%), without differences between studies assessing different type of interventions (p = 0.72) or between study design (p = 0.35). In two studies, females represented the majority of included patients.ConclusionFemale with advanced PD are underrepresented in infusion therapy trials. Most trials have overlooked sex-based biological differences that can impact clinical and functional outcomes, raising concerns about the generalizability of these findings to real-world contexts.

Abstract licence: CC BY

BackgroundDevice-aided therapies, such as levodopa-and apomorphine-based infusion pumps, are widely used for managing patients with Parkinson's disease (PD) with symptoms inadequately controlled by oral medications. Cognitive impairment is a critical factor in selecting an appropriate therapy; however, the effects of levodopa/carbidopa intestinal gel (LCIG) and continuous subcutaneous apomorphine infusion (CSAI) on cognitive function remain debated.ObjectiveThe aim of this review is twofold: i) to provide a comprehensive analysis of the short-term benefits of device-aided infusion therapies on cognitive function, and ii) to evaluate their impact on long-term cognitive trajectories.MethodsA systematic literature search was conducted following PRISMA guidelines in PubMed, CINAHL, Cochrane, EMBASE, and MEDLINE. Narrative synthesis was applied to summarize results.ResultsOut of 1911 studies, 33 were included in this systematic review according to the selected criteria. No studies examined the effects of the newly introduced Foslevodopa/Foscarbidopa (LDp/CDp) nor levodopa/entacapone/carbidopa intestinal gel (LECIG) pump therapy. Seventeen studies addressed the short-term effects of CSAI; seven reported cognitive slowing and two were suggestive of positive effects. Only two studies assessed its impact on long-term cognitive trajectory, showing no significant changes. Thirteen studies examined LCIG's short-term effects; seven reported cognitive changes, with some decreases in executive functions. Two studies explored its long-term cognitive impact, with one reporting improvements.ConclusionsThe cognitive effects of device-aided treatments in PD show substantial variability, and their impact on cognitive function, processing speed, attention, and memory is inconsistent, with some studies reporting impairments and others indicating stability or slight improvements. The heterogeneity in study designs, neuropsychological assessments and coexisting vascular and amyloid pathology further complicates interpretation, underscoring the need for more controlled investigations.

Abstract licence: CC BY