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CompletedNCT04417543Updated Jun 4, 2020

Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

A Phase 1 interventional study of Memantine Hydrochloride and Placebo in Epilepsy, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by Assiut University · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Oct 2018, registered Jun 2020).
Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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)

02

Conditions studied

03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 100 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Memantine hydrochloride group

    included 50 patients who received memantine

    Drug: Memantine Hydrochloride

  • Placebo comparator
    Placebo group

    included 50 patients who received placebo

    Drug: Placebo

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.

    Also known as: Memantine

  • DrugPlacebo

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

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What researchers measure

Primary outcomes

  1. Memory Assessment Scale (MAS)

    This comprehensive battery assesses short-term, verbal and visual memory functioning.

    Time frame: 1.5years

  2. Wechsler Adult Intelligence Scale (WAIS)

    Intelligence quotient (IQ) tests are the primary clinical instruments used to measure adult and adolescent intellience.

    Time frame: 1.5years

  3. 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.

    Time frame: 1.5years

07

Study locations

1 site
  • Salma Mohmed Fahmy
    Assiut, Egypt
08

References and documents

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. PubMed 21304484 ↗
  • 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. PubMed 21964564 ↗
  • 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. PubMed 24365760 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04417543
Lead sponsor
Assiut University
Responsible party
Salma Mohmed (Doctor, Assiut University) — Principal investigator
First posted
Jun 4, 2020
Start date
Oct 1, 2018
Primary completion
Oct 1, 2019
Completion
Jan 15, 2020
Last update
Jun 4, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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