Abstract
Background: The prevalence of cognitive impairment among patients with epilepsy is about 70%. There is still no approved medication for the treatment of this problem. Objectives: The present study aims to assess the safety and efficacy of memantine in improving the cognitive function of patients with epilepsy. Materials & Methods: This is a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial, conducted in a hospital in Tehran, Iran during 2018-2019. Participants were randomly allocated to receive memantine (5 mg/day in the first eight weeks and 10 mg/day in the second eight weeks) or placebo in a 1:1 ratio. Participants underwent the mini-mental state examination (MMSE), montreal cognitive assessment (MoCA), and frontal assessment battery (FAB) before and after the intervention. The primary and secondary measures were safety and change in the cognitive test scores, respectively. Results: Out of 53 allocated participants, 33 completed the study. Drug intolerance including headache, somnolence, and dizziness was not significantly different between the two groups. The Intention-to-Treat analyses demonstrated no significant change in MoCA and FAB scores between the two groups after the intervention, but a significant improvement in the MMSE score of the memantine group (P=0.047) was observed. After controlling confounding factors, there was no significant difference in scores of any cognitive tests between the two groups. Conclusion: Memantine is a safe drug for patients with epilepsy, but it may not exert a beneficial effect on the cognitive function of these patients.
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