Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

Epilepsy Clinical Trial

Official title:

Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417543
• Other study ID #: Memantine in epilepsy
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2018
• Est. completion date: January 15, 2020

Study information

• Verified date: June 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 15, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Epilepsy

Intervention

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

Locations

Country	Name	City	State
Egypt	Salma Mohmed Fahmy	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. Review. — View Citation

Alvarez PS, Simão 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Memory Assessment Scale (MAS)	This comprehensive battery assesses short-term, verbal and visual memory functioning.	1.5years
Primary	Wechsler Adult Intelligence Scale (WAIS)	Intelligence quotient (IQ) tests are the primary clinical instruments used to measure adult and adolescent intellience.	1.5years
Primary	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