Protocol summary

Study aim
Determining and comparing the Effectiveness of memantine and donepezil on the cognitive status of the elderly with vascular dementia
Design
A clinical trial without a control group, with parallel groups, single blind, randomized, phase 3 on 60 patients.The rand function of Excel software was used for randomization.
Settings and conduct
The elderly referring to Amirkola Geriatric Clinic are screened with the MMSE test, and those with a score of less than 24 are introduced to the second colleague to receive medication after performing preliminary tests and ruling out reversible causes of dementia. divides the patients into two groups. In the memantine group, patients are treated with memantine tablets 5 mg twice a day for one to two weeks, then 24 mg twice a day for up to 6 months. Patients in the donepezil group are treated with Donepezil 5 tablets daily for 4 to 6 weeks, then 10 mg daily for up to 6 months. Patients are re-tested with MMSE and Eden Brook tests in the third and sixth month after the start of treatment. In this study, only the first colleague He is not aware of the results and type of medicine of each patient..
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age more than 65 years MMSE score less than 24 with evidence of metabolic disease or evidence in favor of vascular dementia on MRI Exclusion criteria: Patients with psychotic disorders Intellectual disability Patients who are already being treated for cognitive impairment Confirmed history of bipolar disorder and major depression Alzheimer's disease and other neurological diseases
Intervention groups
One group received memantine and the other group received donepezil
Main outcome variables
Variables such as cognitive status, memory, attention and orientation, speech fluency, language and drug side effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190525043700N6
Registration date: 2024-05-29, 1403/03/09
Registration timing: prospective

Last update: 2024-05-29, 1403/03/09
Update count: 0
Registration date
2024-05-29, 1403/03/09
Registrant information
Name
Romina Hamzehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1951
Email address
r.hamzehpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Memantine and Donepezil on the Cognitive Status of the elderly with vascular dementia
Public title
Comparing the Effectiveness of Memantine and Donepezil on elderly with dementia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age > 65 y MMSE Score < 24 + Evidence of metabolic disease Evidence in favor of vascular dementia in MRI
Exclusion criteria:
Patients with psychotic disorders Intellectual disability Patients who are already being treated for cognitive disorders Confirmed history of bipolar disorder or depression Patients with Alzheimer's and other neurological diseases
Age
From 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients in both groups of 30 memantine and donepezil is done by random block allocation method and free website www.randomization.com or http://randomizer.org is used to generate the allocation sequence. The obtained sequence is written on separate sheets and placed in sealed envelopes and given to the second colleague to conduct the study...
Blinding (investigator's opinion)
Single blinded
Blinding description
The first colleague (student) is unaware of the random allocation list and which group each patient is in, and will be informed of the results at the end of the study...
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Health Research Institute - Babol University of Medical Sciences
Street address
Babol, Murad Bey, University Square, Nurse St
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.199

Health conditions studied

1

Description of health condition studied
Vascular dementia
ICD-10 code
F01.5
ICD-10 code description
Vascular dementia

Primary outcomes

1

Description
Investigating the cognitive status by comparing the MMSE and Edenbrook test results at the beginning, during the treatment and at the end of the treatment...
Timepoint
At the beginning of work, 3 months and 6 months after the start of treatment
Method of measurement
Through the Eden Brook test

Secondary outcomes

empty

Intervention groups

1

Description
Patients in the memantine group are treated with memantine tablets 5 mg twice a day for one to two weeks, then 10 mg twice a day for up to 6 months. (From Actover pharmaceutical company)...
Category
Treatment - Drugs

2

Description
Patients in the donepezil group are treated with 5 mg donepezil tablets daily for four to six weeks, then 10 mg daily for up to 6 months..
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic for the elderly in Amirkola city
Full name of responsible person
Dr. Romina hamzehpour
Street address
Naqvi Boulevard, Imam Ali Square
City
Amirkola
Province
Mazandaran
Postal code
4717641367
Phone
+98 911 108 4008
Email
Maryamvajdi1991@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Romina hamzehpour
Street address
Babol, Murad Bey, University Square, Nurse St
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 9592
Email
Maryamvajdi1991@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
90
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
Babol University of Medical Sciences
Full name of responsible person
Dr.Romina hamzehpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol, Modares Street, Shahid Mostafa Khomeini Street, Yahainejad Hospital
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3222 3594
Email
R.hamzehpour@mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Romina hamzehpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farhang Crossroads, Yahainejad Hospital
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3222 3594
Email
R.hamzehpour@mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Maryam vajdi
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Yahyanezhad hospital
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3222 3594
Email
Maryamvajdi1991@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Maintain confidentiality
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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