Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

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

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: Memantine Hydrochloride; Drug: Placebo

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)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Salma Mohmed Fahmy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Memantine hydrochloride group; included 50 patients who received memantine	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.; Other Names: Memantine
Placebo Comparator: Placebo group; included 50 patients who received placebo	Drug: Placebo; Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory Assessment Scale (MAS)	This comprehensive battery assesses short-term, verbal and visual memory functioning.	1.5years
Wechsler Adult Intelligence Scale (WAIS)	Intelligence quotient (IQ) tests are the primary clinical instruments used to measure adult and adolescent intellience.	1.5years
Brief Visuospatial Memory Test-Revised (BVMT-R)	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.	1.5years

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Epilepsy; Cognitive Dysfunction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Memantine
• Other Study ID Numbers: Memantine in epilepsy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes