1. Determining the average score of patients in the two groups studied in the Mini Mental Status test before and after the intervention
2. Determining the average score of patients in the two groups studied in the ADL Questionnaire before and after the intervention
3. Comparing the average score of MMSE test and ADL questionnaire in the two groups studied, before and after the intervention.
Design
double blinded clinical trial
Settings and conduct
Patients are selected among the patients referred to Al-Zahra Hospital Clinic. Patients treated with donepezil will continue to study.
Participants/Inclusion and exclusion criteria
clinically diagnosed Alzheimer's disease ( mild to moderate) - (Based on radiological evidence and patient scores on MMSE)
Having the ability to decide to enter or exit the study
No other neurological diseases and no reversible causes of dementia
Drowsiness
nausea and vomiting
other new complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200411047021N1
Registration date:2020-04-20, 1399/02/01
Registration timing:registered_while_recruiting
Last update:2020-04-20, 1399/02/01
Update count:0
Registration date
2020-04-20, 1399/02/01
Registrant information
Name
Hamed Tuyserkani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3666 4037
Email address
tuyserkani.hamed@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combination of iron , cytidine , uridine , glutamine , pantothenic acid on quality of memory in alzeimer’s patient
Public title
Effect of combination of iron , cytidine , uridine , glutamine , pantothenic acid on quality of memory in alzeimer’s patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with dementia and clinically diagnosed alzheimer's
MMSE score at the beginning of the study range between 24 and 12
observing atrophic evidence in brain CTscan or brain MRI, and rule out other causes of my dementia, including reversible causes, or vascular dementia
having decision making capacity to enter or exit the study
Exclusion criteria:
dissatisfaction for participation in study
history of other neurological diseases
Age
From 60 years old to 95 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
1)participants
2)clinical care givers
Patients are first placed in one of the two "case" or "control" groups. Relevant tests for each patient are completed at the beginning and after the completion of the 3-month intervention period. The case group is treated with the main drug. In order to unify and blind patients at this stage, a placebo containing sugar-composition without any effects on memory tests is prescribed for control group patients.
Grouping and prescribing medication is done by a third party and the interviewer is unaware of the grouping of patients at all stages.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology , Building No. 4 , Isfahan University of Medical Sciences and Health Services, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-02-29, 1398/12/10
Ethics committee reference number
IR.MUI.MED.REC.1398.643
Health conditions studied
1
Description of health condition studied
Alzheimers
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease
Primary outcomes
1
Description
result number of "MMSE" exam (maximum 30 points)
Timepoint
before and after the 12week coarse of treatment
Method of measurement
interview with the patient
2
Description
ADL result number (activity of daily living) / maximum 6 points.
Timepoint
before and after the 12week coarse of treatment
Method of measurement
interview with the patient
Secondary outcomes
empty
Intervention groups
1
Description
In the "case group" The drug supplement is added to the previous drug (here, dopenzyl). The supplement includes iron (0.45 mg), cytidine (75 mg), uridine (75 mg), pantothenic acid (1.05 mg), glutamine (25 mg). Under the "NeuroAge" brand. It is taken twice a day (for 12 weeks) regularly. It should be noted that in the first week and until the appropriate dose is reached, the patient should take 2 times the usual dose (4 times a day) of supplementation. For both groups before the course of treatment, MMSE test, Is done. In addition, the activities of daily living (ADL) questionnaire is completed for patients. After the three-month treatment period, MMSE and ADL are replenished for both groups. Then the data of the two groups are compared. In case of any known or new side effects, patients can stop taking the drug and participate in the study.
Category
Treatment - Drugs
2
Description
Control group: placebo. To eliminate the "placebo effect" in this group ,placebo (sugar compound) was added to the patient's previous medication (Donpezil) for a similar period of time (12 weeks). For Homogenization in Both groups, patients were selected among who had previously been treated with donpezil . For this group, like the intervention group, the MMSE and ADL tests are completed at the beginning and after a 12-week period. Then the data of both groups are compared.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital , neurology clinic
Full name of responsible person
Hamed Tuyserkani
Street address
Al-Zahra University Hospital , Isfahan , Isfahan Province, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir/oldsite/undefined/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ahamd Chitsaz
Street address
Isfahan university of medical science , Hezar jerib Ave. , Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 8134
Email
vcr-office@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
Dr. Ahmad Chitsaz
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
-
City
Isfahan
Province
Isfehan
Postal code
-
Phone
-
Email
chitsaz@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Chitsaz
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
-
City
Isfahan
Province
Isfehan
Postal code
-
Phone
-
Email
chitsaz@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Chitsaz
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
-
City
Isfahan
Province
Isfehan
Postal code
-
Phone
-
Email
chitsaz@med.mui.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
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