Neuroepo multisession Phase II and III

Erythropoietin (EPO) and EPO-derived formulations have been proposed as neuroprotective and neuromodulatory agents with pleiotropic actions that extend beyond erythropoiesis, including anti-inflammatory and anti-oxidative effects, modulation of apoptosis- related signaling, and support of cellular resilience under stress (Maiese et al., 2005; Rey et al., 2019). In Parkinson's disease-relevant contexts, EPO has been linked to mechanisms involving mitochondrial metabolism and pathways relevant to dopaminergic vulnerability, suggesting a plausible route by which exposure could influence systems-level brain function (Rey et al., 2021). At the molecular level, EPO-related transcriptional responses in the brain have been shown to engage synaptic plasticity-associated gene programs, supporting the interpretation that treatment exposure could be accompanied by functional reorganization rather than solely symptomatic modulation (Mengozzi et al., 2012). Clinically and translationally, intranasal NeuroEPO has been evaluated for short-term tolerance in Parkinson's disease, providing practical context for the formulation and administration route used in patient studies (Garcia-Llano et al., 2021). Moreover, prior work has reported that NeuroEPO-related cognitive effects in Parkinson's disease patients can be statistically mediated by EEG source activity, providing precedent for an exposure ? EEG mediator ? outcome framework in this setting (Bringas Vega et al., 2022). Participants were enrolled in a randomized, placebo-controlled study. NeuroEPO exposure was administered according to the intervention protocol (Cuban Public Registry of Clinical Trials: RPCEC00000233-En; https://rpcec.sld.cu/en/trials/RPCEC00000233 -En ), while placebo participants received identical procedures without active compound. Cumulative treatment exposure was quantified as total NeuroEPO dose; placebo participants were coded as dose = 0. Clinical and EEG assessments were conducted at baseline (pre-intervention) and after 9 months of completion of the intervention period (post-intervention). Baseline demographic and clinical characteristics were summarized for the NeuroEPO and placebo groups. Baseline variables included age (years), education (years), and study-coded measures of disease duration/progression and motor severity available in the source dataset. The motor performance was assessed by two certified neurologists using the Unified Parkinson Disease Rating Scale MDS UPDRS III item scores collected at pre and post-intervention visits (Goetz et al., 2008), where the severity variable was recorded as an ordinal 0-4 grade, with lower values indicating better motor status, and was used for baseline description only.