Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

Study Overview
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Brief Summary
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Evaluate the efficacy of memantine on improving the cognitive impairment in patient with epilepsy

Detailed Description
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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)

Official Title
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Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Memantine Hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 100 patients divided into two groups each group 50patients
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |