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Comparison the effects of Donepezil, Galantamine,Rivastigmine and Memantine on transcranial Doppler sonography and MMSE in patients with vascular dementia.

Protocol summary

Study aim
Comparison the changes of transcranial Doppler sonography (TCD) and Mini mental state examination (MMSE) in patients with vascular dementia treated with Rivastigmine, Memantine , Galantamine and Donepezil .
Design
This study is double blinded clinical trial that conducted on 44 patients with vascular dementia in Shafa hospital in Kerman in 1397. Patients are divided into 4 groups of 11 patients. Each group is treated with either Donepezil , memantine, galanthamine, or rivastigmine. TCD is performed on starting and after 3 months of treatment. MMSE is also evaluated before and after intervention.
Settings and conduct
This study is double blinded clinical trial that conducted on 44 patients with vascular dementia in Shafa hospital in Kerman in 1397. Patients are divided into 4 groups of 11 patients. Each group is treated with either Donepezil , memantine, galanthamine, or rivastigmine. TCD is performed on starting and after 3 months of treatment. MMSE is also evaluated before and after intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria for the study is the patients with vascular dementia.Patients are excluded from the study if there is any underlying diseases other than Diabetes, hypertention,hyperlipidemia and ischemic heart disease, including history of depression,memory and speech impairment,taking any medication such as sedative drugs and substance abuse, except for the control of underlying diseases.
Intervention groups
Goup1:patients with vascular dementia treated with Rivastigmine. Goup2:patients with vascular dementia treated with Donepezil. Goup3patients with vascular dementia treated with Galantamine. Goup4:patients with vascular dementia treated with Memantine.
Main outcome variables
Measurement of mean flow velocity of Anterior cerebral artery(ACA),Middle cerebral artery(MCA),Posterior cerebral artery(PCA)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181210041912N1
Registration date: 2019-01-14, 1397/10/24
Registration timing: registered_while_recruiting

Last update: 2019-01-14, 1397/10/24
Update count: 0
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
Ali Farzanmoghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3725 1254
Email address
alifarzan57@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of Donepezil, Galantamine,Rivastigmine and Memantine on transcranial Doppler sonography and MMSE in patients with vascular dementia.
Public title
Comparison the effects of Donepezil, Galantamine,Rivastigmine and Memantine on vascular dementia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with vascular dementia in Kerman city
Exclusion criteria:
Having any underlying condition other than diabetes, hypertension, hyperlipidemia, and ischemic heart disease, including history of depression and memory and speech impairment. Use of any medication, such as sedative medicines and substance abuse, except medicines for controlling diabetes, hypertension, hyperlipidemia, and ischemic heart disease.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 44 patients with vascular dementia referring to a neurologist were randomly divided into 4 groups of 11 patients. The randomization method is simple and How to create a sequence. is random.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was carried out for patients with vascular dementia at the onset of ultrasound and MMSE intervention and then referred to one of the contributors who are unaware of the type of medication. After receiving the code, the patient is treated with one of the medications in the uncertain packing (A, B, C, D) until the end of the intervention, which is repeated in the above procedures.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Campus of the University of Medical Sciences, the center of seven Alavi Gardens, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-12-10, 1397/09/19
Ethics committee reference number
IR.KMU.AH.REC.1397.093

Health conditions studied

1

Description of health condition studied
Vascular Dementia
ICD-10 code
I63
ICD-10 code description
occlusion and stenosis of cerebral and precerebral arteries (including truncus brachiocephalicus), resulting in cerebral infarction

Primary outcomes

1

Description
Transcranial Doppler Sonography
Timepoint
Performing transcranial doppler sonography at the beginning of the study and three months after taking any of the donepezill, memantine, galanthamine or rivastigmine drugs
Method of measurement
Doppler Sonography machine

Secondary outcomes

1

Description
Mini Mental State Examination
Timepoint
Measurement of the MMSE at the beginning of the study and three months after the onset of consumption, which of the drugs donepezil, memantine, galantamine or rivastigmine
Method of measurement
By number from zero to thirty

Intervention groups

1

Description
Intervention group: Donpezil starts at 5mg / day and increases to 10mg / day within two weeks and lasts up to three months.
Category
Treatment - Drugs

2

Description
Intervention group: Rivastigmine starts at 1.5mg twice daily and increases to 3mg twice a week within a week.
Category
Treatment - Drugs

3

Description
Intervention group: Memantine starts at 5mg daily and increases to 10mg per day in one week.
Category
Treatment - Drugs

4

Description
Intervention group: Galanthambon is given 8mg daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Farhad Iranmanesh
Street address
Shafa hospital,Kosar Blvd
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Fax
+98 34 3211 5783
Email
shafahospital@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/sh

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farhad Iranmanesh
Street address
Research and Technology Assistance, Somayeh Intersection (Tahmasebabad), Ibn Sina Avenue, .Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Fax
+98 34 3226 3857
Email
fpp_farhad@yahoo.com
Web page address
http://kmu.ac.ir/fa/vcrt
Grant name
Deputy of Research and Technology of Kerman University of Medical Sciences
Grant code / Reference number
411389339391
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Farhad Iranmanesh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Shafa Hospital, Kosar Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
fpp_farhad@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Kave Shafiee
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Shafa Hospital, Kosar Blvd,Kerman
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
kshafiee@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ali Farzanmoghadam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Shafa hospital,Kosar Blvd
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 35 3725 1254
Email
alifarzan57@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of transcranial doppler sonography that shares all the data after unidentifiable individuals.
When the data will become available and for how long
After completing the transcranial doppler sonography
To whom data/document is available
Faculty Members of Medical Universities across Iran
Under which criteria data/document could be used
With written request for reuse of files
From where data/document is obtainable
Postcode: Kerman, Kowsar Blvd, Shafa Hospital, Ali Farzan Moghadam Email:alifarzan57@yahoo.com phone number:09132512862
What processes are involved for a request to access data/document
The written and formal request of the applicant who has been approved by the research assistant at the university of the applicant's workplace will be sent no later than one week later.
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