Effect of Memantine on Cognitive Impairment in Patients With Epilepsy
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Memory Assessment Scale (MAS)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 than
- •Patients with severe medical disorders
Arms & Interventions
Placebo group
included 50 patients who received placebo
Intervention: Placebo (Drug)
Memantine hydrochloride group
included 50 patients who received memantine
Intervention: Memantine Hydrochloride (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Salma Mohmed
Doctor
Assiut University