Bringas Vega Maria L, Pedroso Ibáñez Ivonne, Razzaq Fuleah A, Zhang Min, Morales Chacón Lilia, Ren Peng, Galan Garcia Lidice, Gan Peng, Virues Alba Trinidad, Lopez Naranjo Carlos, Jahanshahi Marjan, Bosch-Bayard Jorge, Valdes-Sosa Pedro A
Ministry of Education (MOE) Key Lab for Neuroinformation, The Clinical Hospital of Chengdu Brain Science Institute, University of Electronic Science and Technology of China, Chengdu, China.
International Center of Neurological Restoration (CIREN), La Habana, Cuba.
Front Neurosci. 2022 Jun 30;16:841428. doi: 10.3389/fnins.2022.841428. eCollection 2022.
We report on the quantitative electroencephalogram (qEEG) and cognitive effects of Neuroepo in Parkinson's disease (PD) from a double-blind safety trial (https://clinicaltrials.gov/, number NCT04110678). Neuroepo is a new erythropoietin (EPO) formulation with a low sialic acid content with satisfactory results in animal models and tolerance in healthy participants and PD patients. In this study, 26 PD patients were assigned randomly to Neuroepo ( = 15) or placebo ( = 11) groups to test the tolerance of the drug. Outcome variables were neuropsychological tests and resting-state source qEEG at baseline and 6 months after administering the drug. Probabilistic Canonical Correlation Analysis was used to extract latent variables for the cognitive and for qEEG variables that shared a common source of variance. We obtained canonical variates for Cognition and qEEG with a correlation of 0.97. Linear Mixed Model analysis showed significant positive dependence of the canonical variate cognition on the dose and the confounder educational level ( = 0.003 and = 0.02, respectively). Additionally, in the mediation equation, we found a positive dependence of Cognition with qEEG for ( = < 0.0001) and with dose ( = 0.006). Despite the small sample, both tests were powered over 89%. A combined mediation model showed that 66% of the total effect of the cognitive improvement was mediated by qEEG ( = 0.0001), with the remaining direct effect between dose and Cognition ( = 0.002), due to other causes. These results suggest that Neuroepo has a positive influence on Cognition in PD patients and that a large portion of this effect is mediated by brain mechanisms reflected in qEEG.
我们在一项双盲安全性试验（https://clinicaltrials.gov/，编号NCT04110678）中报告了Neuroepo对帕金森病（PD）患者的定量脑电图（qEEG）及认知方面的影响。Neuroepo是一种新型促红细胞生成素（EPO）制剂，唾液酸含量低，在动物模型中取得了满意结果，且健康参与者和PD患者对其耐受性良好。在本研究中，26名PD患者被随机分为Neuroepo组（n = 15）或安慰剂组（n = 11）以测试该药物的耐受性。观察变量为基线时以及给药6个月后的神经心理学测试和静息态源qEEG。采用概率典型相关分析来提取认知变量和qEEG变量中具有共同方差来源的潜在变量。我们获得了认知与qEEG的典型变量，其相关性为0.97。线性混合模型分析显示典型变量认知对剂量和混杂因素教育水平有显著正相关性（分别为p = 0.003和p = 0.02）。此外，在中介方程中，我们发现认知与qEEG（p = < 0.0001）以及与剂量（p = 0.006）之间存在正相关性。尽管样本量较小，但两项测试的效能均超过89%。一个联合中介模型显示，认知改善总效应的66%由qEEG介导（p = 0.0001），其余剂量与认知之间的直接效应（p = 0.002）则归因于其他原因。这些结果表明，Neuroepo对PD患者的认知有积极影响，且这种影响的很大一部分是由qEEG所反映的脑机制介导的。
