Safety and efficacy of Memantine on cognitive profile of epileptic patients; A pilot, randomized, double-blinded, placebo-controlled clinical trial

Background and Aim : The prevalence of cognitive impairment among epileptic patients is around 40%. Disturbances in cognitive domains, especially memory, can lead to forgetting medications and poor seizure control and no medication has been approved for treatment of this problem yet. In previous studies, Memantine, a noncompetitive N-Methyl-D-aspartate (NMDA) receptor antagonist, has been recommended as a new treatment for this issue. It can block the excitotoxicity pathway on hippocampus which can prevent hippocampal sclerosis, following seizures and memory dysfunction.Methods : This was a pilot, randomized, double-blinded, placebo-controlled parallel group trial conducted in the Neurology Clinic of Imam Khomeini Hospital. Participants were randomly assigned to two groups to receive either Memantine or Placebo. They received 5mg of Memantine or placebo for the first eight weeks and 10 mg for the second eight weeks. Safety of this drug was our primary outcome. Also, subjects did several cognitive tests, MMSE (Mini-mental State Examination), MoCA (Montreal Cognitive Assessment) and FAB (Frontal Assessment Battery) during the first and last visit. Our secondary measures were obtained from comparing these two results.Results : Sixty eligible patients have participated in the study and 37 of them continued the study to the end, as two were diagnosed with pseudo seizure, three patients had drug intolerance and the rest of the exclusions were due to lack of follow up or compliance. Our analysis demonstrates no significant change in MMSE and MoCA score after intervention in either groups (P-value> 0.05), but a significant improvement in FAB score was seen after adjustment for age, baseline FAB and anti-epileptic drugs at the end of the 16th week (P-value=0.030).Conclusion : Our data shows that Memantine is a safe and useful drug in the management of cognitive difficulties in patients with epilepsy. Our results revealed that Memantine is particularly effective in improving executive function in these patients.

کلیدواژه ها:

Epilepsy ، Memantine ، Cognition