Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

Overview

Evaluate the efficacy of memantine on improving the cognitive impairment in patient with epilepsy

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: October 1, 2019

Detailed Description

Epilepsy is a complex disorder, which involves much more than seizures, encompassing a range of associated comorbid health conditions that can have significant health and quality-of-life implications. Of these comorbidities, cognitive impairment is one of the most common and distressing aspects of epilepsy. Excito-toxicity, mediated by glutamate acting on N-methyl-D-aspartate (NMDA) receptors in the hippocampus, can cause memory dysfunction in epilepsy . Memantine is a low-affinity voltage-dependent uncompetitive antagonist of the NMDA-type glutamate receptor . It also has antioxidant property and increases production of brain derived neurotropic factor (BDNF)

Interventions

  • Drug: Memantine Hydrochloride
    • Memantine is a low-affinity voltage-dependent uncompetitive antagonist of the NMDA-type glutamate receptor .Memantine hydrochloride tablet was started at the dose of 5 mg once daily orally, and the same dose was given for 3months and dose is titrated to 10 mg once daily orally for the remaining 3months. Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.
  • Drug: Placebo
    • Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.

Arms, Groups and Cohorts

  • Active Comparator: Memantine hydrochloride group
    • included 50 patients who received memantine
  • Placebo Comparator: Placebo group
    • included 50 patients who received placebo

Clinical Trial Outcome Measures

Primary Measures

  • Memory Assessment Scale (MAS)
    • Time Frame: 1.5years
    • This comprehensive battery assesses short-term, verbal and visual memory functioning.
  • Wechsler Adult Intelligence Scale (WAIS)
    • Time Frame: 1.5years
    • Intelligence quotient (IQ) tests are the primary clinical instruments used to measure adult and adolescent intellience.
  • Brief Visuospatial Memory Test-Revised (BVMT-R)
    • Time Frame: 1.5years
    • The current revised version of the BVMT, a visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with idiopathic epilepsy. – Normal brain imaging (CT brain). – Patients on anti epileptic drugs more than 6 months. – No more than two fits per month. – Score of Mini mental state examination (10-24), mild and moderate cognitive impairment. – No other medical disorders. Exclusion Criteria:

  • Progressive neurological diseases. – Abnormal brain imaging (CT brain). – More than two fits per month. – Patients with severe cognitive impairment, score of MMSE less than10. – Patients with severe medical disorders

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Salma Mohmed, Doctor – Assiut University

References

Bell B, Lin JJ, Seidenberg M, Hermann B. The neurobiology of cognitive disorders in temporal lobe epilepsy. Nat Rev Neurol. 2011 Mar;7(3):154-64. doi: 10.1038/nrneurol.2011.3. Epub 2011 Feb 8.

Aggleton JP. Multiple anatomical systems embedded within the primate medial temporal lobe: implications for hippocampal function. Neurosci Biobehav Rev. 2012 Aug;36(7):1579-96. doi: 10.1016/j.neubiorev.2011.09.005. Epub 2011 Sep 24.

Alvarez PS, Simao F, Hemb M, Xavier LL, Nunes ML. Effects of undernourishment, recurrent seizures and enriched environment during early life in hippocampal morphology. Int J Dev Neurosci. 2014 Apr;33:81-7. doi: 10.1016/j.ijdevneu.2013.12.004. Epub 2013 Dec 21.

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