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OpenTrials
Completed

NCT Number: NCT04417543

Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Salma Mohmed Fahmy

Asyut, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Memantine Hydrochloride

Drug

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.

Other names: Memantine

Placebo

Drug

Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.

Primary outcomes

  1. Memory Assessment Scale (MAS)

    Time frame: 1.5years

    This comprehensive battery assesses short-term, verbal and visual memory functioning.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 4, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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