The Comparative study about effect of Donepezil with and without Memantine on recovery of cognitive, linguistic dysfunctions and disability rating in traumatic brain injury patients during the subacute phase
Regarding to advantage effect of combination of Memantine and Donepezil on the induction of central cholinergic level in animal models, one double blind randomized controlled clinical trial study as consecutive sampling is designed with aim of effect of treatment of combination of Memantine and donepezil on recovery of cognitive and linguistic disorders and disability rate is designed. 162 patients with moderate and severe traumatic brain injury aged 18-60 years having post-traumatic aphasia and cognitive deficit take part in the project contently written. In the first all demographic and para-clinical information are entered in especial form. Subjects are examined with respect to disability rate, cognitive function and aphasia quotient before pharmacotherapy. Intervention is started 4 weeks after discharge. In first 4 weeks, Donepezil group receive 5 mg Donepezil and Memantine placebo, combined group use 5mg Donepezil and 5 mg Memantine, placebo group is given Donepezil and Memantine placebo. Participants are examined by physician in the end of first 4 weeks. Then interventional approach for groups that receive drugs is continued whereas drug dose increase to 10 mg for each of them. Patients are evaluated respecting to disability rate, cognitive function and aphasia quotient 12 weeks post of intervention onset again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013041613027N1
Registration date:2013-05-07, 1392/02/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-05-07, 1392/02/17
Registrant information
Name
Sara Ramezani Kapourchali
Name of organization / entity
Guilan Road Trauma Research Centre
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 8373
Email address
s.ramezanislp@gmail.com
Recruitment status
Recruitment complete
Funding source
Guilan university of medical sciences
Expected recruitment start date
2013-09-22, 1392/06/31
Expected recruitment end date
2015-09-22, 1394/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparative study about effect of Donepezil with and without Memantine on recovery of cognitive, linguistic dysfunctions and disability rating in traumatic brain injury patients during the subacute phase
Public title
The effect of Donepezil and Memantine combinition on treatment of traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aphasia patients having post-traumatic cognitive deficit; moderate & severe traumatic brain injury according to GCS at first 24 h; age range between 18-60 years; GOS score 4 & 5; at least 4 years formal education; maximum of aphasia quotient 75 based on P.AD; moderate and severe cognitive deficit(MMSE score<17); post onset discharge time 2-4 weeks(sub-acute phase).
Exclusion criteria: history of neurological disease including CVA, brain tumor, epilepsy, seizure, Parkinson and dementia...; previous brain trauma; history of psychiatric disorder and using of antipsychotic & antidepressant drugs; history of drug abuse and pre-existing verbal and cognitive deficit; exist of deafness and blindness; appearance of drug's side effects; exist of renal disease, heart disease, hypertension and unwillingness for continue of the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
162
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Guilan university of medical sciences
Street address
Rasht, Namjou avenue, Research Guilan university of medical sciences
City
Rasht
Postal code
Approval date
2013-02-09, 1391/11/21
Ethics committee reference number
1910396410
Health conditions studied
1
Description of health condition studied
Traumatic brain injury
ICD-10 code
G94*
ICD-10 code description
other disorders of brain in diseases classified elsewhere
Primary outcomes
1
Description
disability rate
Timepoint
before of intervention and 3 months after intervention onset
Method of measurement
disability rate scale (DRS)
2
Description
aphasia quotient
Timepoint
befor of intervention and 3 months after intervention onset
Method of measurement
Persian. aphasia diagnosis (P.AD)
3
Description
Cognitive function
Timepoint
before of intervention and 3 month after intervention onset
Method of measurement
mini-mental state examination(MMSE)
Secondary outcomes
1
Description
side effects of drugs
Timepoint
1 month and 3 months after intervention onset
Method of measurement
observation and examination
Intervention groups
1
Description
Drug intervention of Donepezil without Memantine in dosage of 5 mg during 1 month then induction of drug dosage to 10 mg for 2 months . in first 1 month for Donepezil group one tablet of 5 mg Donepezil and half tablet Memantin placebo at evening,whereas, next 2 months for Donepezil group one tablet of Donepezil 10 mg and half tablet of Memantine placebo at evening and half tablet of Memantin placebo at morning,
Category
Treatment - Drugs
2
Description
Drug intervention of Donepezil with Memantine carries out in dosage of 5 mg for each of them during 1 month then will be continued by induction of drug dosage to 10 mg for 2 months. In combined group (Donepezil+Memantine) is offered one tablet of Donepezil 5 mg and half tablet of Memantine 10 mg at evening in first 1 month. Whereas, next 2 months this group is used one tablet of Donepezil 10 mg and half tablet of Memantine 10 mg at evening and half tablet of Memantine 10 mg at morning.
Category
Treatment - Drugs
3
Description
Control group receive placebo similar to Memantin and Donepezil. in first 1 month one and half tablet of placebo is used daily(one tablet of Donepezil placebo and half tablet of Memantine placebo at evening) in next 2 month 2 tablet of placebo is used daily (one tablet of Donepezil placebo at evening and half tablet of Memantin placebo at morning and half other at evening) .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina educational & therapeutical center
Full name of responsible person
Dr. Sara Ramezani
Street address
, Poursina educational & therapeutical center, Namjou avenue
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research adjutancy ,Guilan university of medical sciences
Full name of responsible person
Dr. Rasoul Tabari
Street address
Rasht, Namjou avenue, Research adgutancy, class2
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research adjutancy ,Guilan university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan Road trauma research center, Rasht, Guilan university of medical sciences
Full name of responsible person
Dr. Sara Ramezani
Position
MD, researcher
Other areas of specialty/work
Street address
Poursina educational & therapeutical center, Namjou avenue
City
Rasht
Postal code
4193713191
Phone
+98 13 1323 8373
Fax
+98 13 1323 8373
Email
s.ramezanislp@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan Road Trauma Research Center
Full name of responsible person
Dr. Shahrokh Yousefzadeh Chabok
Position
Neurosurgen, associated professor
Other areas of specialty/work
Street address
Poursina educational & therapeutical center, Namjou avenue
City
Rasht
Postal code
4193713191
Phone
+98 13 1323 8373
Fax
Email
sh.yousefzadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan Road Trauma Research Center
Full name of responsible person
Dr. Zoheir Reihanian
Position
MD, Neurosurgery resident
Other areas of specialty/work
Street address
Neurosurgery ward, Poursina educational & therapeutical center, Namjou avenue
City
Rasht
Postal code
Phone
Fax
Email
zoheir.reihanian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)