Cognitive follow-up six and nine months after intervention with NeuroEPO in Cuban Parkison's patients
Description
The study was part of a randomized double-blind physician-lead placebo-controlled trial to evaluate the safety of NeuroEPO in Parkinson’s Disease patients (https://clinicaltrials.gov/ number NCT04110678) with motor and cognitive secondary outcomes measures. The sample was composed of twenty-six patients (10 women) with a clinical diagnosis of idiopathic Parkinson’s disease according to the UK Brain Bank Criteria. The average age was 53.88 years (SD=7.66) and the duration of disease was 5.5 years (SD=3.49). The patients were in stage Ⅰ-Ⅱ of Hoehn and Yahr. The NeuroEPO group included fifteen patients (7 women) who received a weekly 1mL dose of intranasal NeuroEPO for 5 weeks and the placebo group included eleven patients (3 women) who received a similar formulation containing the same ingredients except for EPO. Six months after the safety trial finished, 10 patients from the EPO group and 8 patients from the original placebo group received 9 months of intensive NeuroEPO treatment, with 1mL bulb, 3 times per week, for one month (induction phase) and later 1/2 bulb three times per week, for eight months. To evaluate the motor symptoms the Unified Parkinson Disease Rating Scale (UPDRS) motor section was used. For evaluation of cognition the neuropsychological battery included the Mini Mental State Examination, Dementia Rating Scale (global cognitive functioning), the Rey Auditory Verbal Learning test (episodic verbal memory), the Working Memory Index from WAIS Ⅲ (working memory) and the Rey Complex Figure, copy and delayed recall/reproduction of the copy (visuospatial ability and non-verbal memory), Delis-Kaplan verbal fluency, Trail-Making, and the Stroop color word Interference test and the Frontal Assessment Battery were used to assess executive functions. Mood was assessed with the Hospital Anxiety Depression Scale (HADS). For the follow-up of the patients 9 months after the second intervention, a subset of the full battery was employed.