Effects of N-Pep-12 dietary supplementation on neurorecovery after ischemic stroke
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ORIGINAL ARTICLE
Effects of N-Pep-12 dietary supplementation on neurorecovery after ischemic stroke Maria Balea 1,2 & Codruta Birle 1,2 & Cezara Costin 1,2 & Julia Marton 1 & Ioana Anamaria Muresanu 1 & Nicoleta Jemna 1 & Livia Livint Popa 1,2 & Dana Slavoaca 1,2 & Olivia Verisezan Rosu 1,2 & Adina Stan 1,2 & Vitalie Vacaras 1,2 & Stefan Strilciuc 1,2 & Dafin F. Muresanu 1,2 Received: 25 June 2020 / Accepted: 1 September 2020 # Fondazione Società Italiana di Neurologia 2020
Abstract Background The aim of the study was to evaluate the effects of N-Pep-12 dietary supplementation on neurorecovery of middleaged and older adults with cognitive impairment after ischemic stroke, using neuropsychological outcome scales. Methods This was a pilot randomized-controlled, phase IV, academic clinical trial that aimed to assess the effect and the safety of a single daily dose of oral 90 mg of N-Pep-12 for 90 days in supporting neurorecovery, as compared with a control group, performed on middle-aged and older adults after supratentorial ischemic stroke. Results Study group differences in baseline changes at day 90 for Montreal Cognitive Assessment (MoCA), Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale, Color Trails 1 and Symbol Search (number incorrect) were statistically significant (Mann-Whitney U test). For MoCA at day 90, a borderline ‘intermediate effect’ in favour of N-PEP-12 was observed (dCohen = 0.491, η2 = 0.057, OR = 2.436, p = 0.010). HADS Anxiety and Color Trails 1 at day 90 registered a ‘small-tointermediate’ effect in favour of N-PEP-12 (dCohen = 0.424, η2 = 0.043, OR = 2.157, p = 0.026; dCohen = 0.481, η2 = 0.055, OR = 2.3927, p = 0.013, respectively). For symbol search errors, an ‘intermediate’ effect in favour of the control group was observed (dCohen = 0.501, η2 = 0.059, OR = 2.4811, p = 0.007). Conclusion This exploratory clinical trial indicates a signal for the benefit of dietary supplementation with N-Pep-12 for the enhancement of neurorecovery after supratentorial ischemic stroke. Keywords Ischemic stroke . N-PEP-12 . Neurorecovery
Introduction Stroke will most likely remain a giant contributor to all-cause mortality worldwide well beyond this decade [1], causing widespread disability even in survivors of minor events [2, 3]. In addition to motor dysfunction, speech disturbances and other complications, cognitive impairment is a common Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10072-020-04707-9) contains supplementary material, which is available to authorized users. * Dafin F. Muresanu [email protected] 1
RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878 Cluj-Napoca, Romania
2
Department of Neurosciences, Iuliu Hațieganu University of Medicine and Pharmacy, No. 37 Mircea Eliade Street, 4004878 Cluj-Napoca, Romania
finding in individuals who have suffered stroke. Contrary to physical impairment, which usually improves during the recovery phase, cognitive deficits tend to progressively wo
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