Maria Balea1,2, Codruta Birle1,2, Cezara Costin1,2, Julia Marton1, Ioana Anamaria Muresanu1, Nicoleta Jemna1, Livia Livint Popa1,2, Dana Slavoaca1,2, Olivia Verisezan Rosu1,2, Adina Stan1,2, Vitalie Vacaras1,2, Stefan Strilciuc1,2, Dafin F Muresanu3,4. 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. 3. RoNeuro Institute for Neurological Research and Diagnostic, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania. dafinm@ssnn.ro. 4. Department of Neurosciences, Iuliu Hațieganu University of Medicine and Pharmacy, No. 37 Mircea Eliade Street, 4004878, Cluj-Napoca, Romania. dafinm@ssnn.ro.
Abstract
BACKGROUND: The aim of the study was to evaluate the effects of N-Pep-12 dietary supplementation on neurorecovery of middle-aged 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-to-intermediate' 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.
BACKGROUND: The aim of the study was to evaluate the effects of N-Pep-12 dietary supplementation on neurorecovery of middle-aged 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-to-intermediate' 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.
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Authors: Livia Livint Popa; Mihaela Iancu; Gheorghe Livint; Maria Balea; Constantin Dina; Vitalie Vacaras; Cristian Vladescu; Laura Balanescu; Anca Dana Buzoianu; Stefan Strilciuc; Dafin Muresanu Journal: Neurol Sci Date: 2021-06-25 Impact factor: 3.307