Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

Phase 1

Completed

• Conditions: Epilepsy
• Interventions: Drug: Placebo; Drug: Memantine Hydrochloride

• Registration Number: NCT04417543
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-10-01
• Study Completion: 2020-01-15
• Status Verified: 2020-06
• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-03
• Last Update Submitted: 2020-06-03
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	included 50 patients who received placebo
Memantine hydrochloride group	Memantine Hydrochloride	included 50 patients who received memantine

Primary Outcome Measures

Name	Time	Method
Memory Assessment Scale (MAS)	1.5years	This comprehensive battery assesses short-term, verbal and visual memory functioning.
Wechsler Adult Intelligence Scale (WAIS)	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)	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.

Trial Locations

Locations (1)

Salma Mohmed Fahmy; 🇪🇬 Assiut, Egypt