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Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04417543
Enrollment
100
Registered
2020-06-04
Start date
2018-10-01
Completion date
2020-01-15
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

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)

Interventions

DRUGMemantine 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.

DRUGPlacebo

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

100 patients divided into two groups each group 50patients

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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 than10. * Patients with severe medical disorders

Design outcomes

Primary

MeasureTime frameDescription
Memory Assessment Scale (MAS)1.5yearsThis comprehensive battery assesses short-term, verbal and visual memory functioning.
Wechsler Adult Intelligence Scale (WAIS)1.5yearsIntelligence quotient (IQ) tests are the primary clinical instruments used to measure adult and adolescent intellience.
Brief Visuospatial Memory Test-Revised (BVMT-R)1.5yearsThe 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026