Evaluation and comparison of the effects of Donepezil and Memantine on improving cognitive function in patients with temporal lobe epilepsy
Design
This study is a non-randomized clinical trial without control group with parallel groups. Epileptic patients referred to clinic are divided into two groups in decussate form. The first group receives Donepezil (10 mg daily) and the secong group receives Memantine (10 mg daily) for 16 weeks. After treatment, patient's cognitive function is evaluated and compared between two groups.
Settings and conduct
In this study patients with temporal lobe epilepsy referred to Alzahra and Kashani hospital clinics are selected and divided into two groups in decussate way. The firs group and second groups are treated with Donepezil and Memantine, respectively. Cognitive function is evaluated in both groups before and after intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1)Age between 18-55 years; 2)Having temporal lobe epilepsy; 3)Have no other neurological disease; 4)Use no medication for treating cognitive disorders; 5)patient's willingness to participate in this study.
Exclusion criteria: 1)Mental retardation; 2)Having progressive neurological disease; 3)Having sensitivity to Donepezil or Memantine.
Intervention groups
In this study, in the first group 10 mg Donepezil is prescribed daily for 16 weeks. In second group, 10 mg Memantine is prescribed daily for 16 weeks.
Main outcome variables
The score of Montreal Cognitive Assessment test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180113038344N1
Registration date:2018-03-18, 1396/12/27
Registration timing:prospective
Last update:2018-03-18, 1396/12/27
Update count:0
Registration date
2018-03-18, 1396/12/27
Registrant information
Name
Marjan Oustad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3785 0698
Email address
oustadmarjan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Donepezil and Memantine on improving cognitive function in patients with temporal lobe epilepsy
Public title
Effect of Donepezil and Memantine on improving cognitive function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having age between 18-55 years
Having temporal lobe epilepsy
Have no other neurological disease
Use no medications for treating cognitive disorders
willingness to participate in this study
Exclusion criteria:
Having mental retardation
Having progressive neurological disease
Having sensitivity to Memantine or Donepezil
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
Hezar jarib street, Isfahan University of Medical Science
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.MUI.REC.1396.3.530
Health conditions studied
1
Description of health condition studied
Temporal lobe epilepsy
ICD-10 code
G40.2
ICD-10 code description
Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
Primary outcomes
1
Description
The score of Montreal Cognitive Assessment test
Timepoint
Before and immediately after intervention
Method of measurement
Montreal Cognitive Assessment questionnaire
Secondary outcomes
1
Description
Incidence of sensitivity to Memantine
Timepoint
During intervention
Method of measurement
observation
2
Description
Incidence of sensitivity to Donepezil
Timepoint
During intervention
Method of measurement
observation
Intervention groups
1
Description
Intervention group: In this group 10 mg Donepezil is prescribed daily for 16 weeks that is produced by Jalinous Pharmacological Company.
Category
Treatment - Drugs
2
Description
Intervention group: In this group 10 mg Memantine is prescribed daily for 16 weeks that is produced by Sobhan Pharmacological Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mohammadreza Najafi
Street address
Alzahra Hospital, Sofe Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
najafi@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Mohammadreza Najafi
Street address
Kashani Hospital, Kashani Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3233 0091
Email
najafi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian
Street address
Isfahan University of Medical Science, Hezar jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Najafi@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marjan Oustad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Isfahan University of Medical Science, Hezar jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
oustadmarjan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Najafi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Isfahan University of Medical Science, Hezar jarib Strret
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
najafi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marjan Oustad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Isfahan University of Medical Science, Hezar jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
oustadmarjan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available