Determination of the effect of Silymarin on imaging and blood biomarkers of Alzheimer's patients with dyslipidemia
Design
This is a double-blind phase 3 clinical trial and using block randomization method, 36 patient with Alzheimer's disease are divided into 3 equal groups. Rand function of Excel software is used for randomization.
Settings and conduct
Neuropsychological evaluations are performed for 36 AD patients who have referred to Ziaeian and Roozbeh hospitals at Tehran city. MRS imaging and biomarkers are performed at Saadatabad Imaging Center in Tehran. Blood biomarkers and biochemical parameters are analyzed in the comprehensive laboratory of Iran University of Medical Sciences. Six months later, all assessments and tests will be performed again. Blinding of patients is facilitated by the use of similar medicine and placebo. Neurologist, other researchers and data analyzer are also blind.
Participants/Inclusion and exclusion criteria
Inclusion-criteria:1- 60-80 years, 2-with sporadic mild-degree Alzheimer's disease, 3-No history of brain-surgery and chronic-renal failure.
Exclusion criteria: 1-Smoking and drug abuse during the study, 2-Lack or irregular use of medications.
Intervention groups
Patients will be divided into the following 3-groups:
1-First intervention group: Patients receive routine medications and three 140 mg Silymarin tablets daily for 6-months.
2-Control group: Patients receive routine medications and placebo (three-times a day) for 6 months.
3-Second intervention group: Patients receive routine medications and three Rosuvastatin tablets a day for 6 months.
Main outcome variables
Determination of concentration of the brain metabolites, mental and cognitive status and serum level of antioxidant and diagnostic markers in Alzheimer's patients, before and 6 months after intervention in relevant groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210901052360N1
Registration date:2021-10-26, 1400/08/04
Registration timing:registered_while_recruiting
Last update:2021-10-26, 1400/08/04
Update count:0
Registration date
2021-10-26, 1400/08/04
Registrant information
Name
Auob Rustamzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4567
Email address
rostamzadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-25, 1400/08/03
Expected recruitment end date
2022-06-10, 1401/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of Silymarin on blood and imaging biomarkers of Alzheimer's patients with dyslipidemia
Public title
The effect of Silymarin on dyslipidemic patients with Alzheimer's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has sporadic Alzheimer's disease.
The patient has a mild degree of Alzheimer's disease.
The patient has dyslipidemia.
Patients whose Alzheimer's disease has been confirmed by clinical evaluation or imaging techniques and biochemical tests by a neurologist.
Exclusion criteria:
The patient has no history of viral hepatitis.
The patient has not had alcohol misuse, smoking or drug abuse in the last month.
The patient should not take chemotherapy drugs.
The patient does not have active rheumatic disorders.
The patient does not have diabetes and uncontrolled hypertension.
The patient has no history of brain surgery.
The patient does not have advanced heart failure, acute cardiovascular disease, or chronic renal failure.
The patient does not have hypothyroidism.
Age
From 60 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study is done through block randomization with size of 6. The randomization unit is of individual type. The randomization tool of this study is Excel software and this software is also used to create random sequences. For allocation concealment, a clinical trial specialist who is not a project collaborator in a separate center, after registering the participants' information, defines the separate code on medicine box for each patient and informs the research team about the code.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding of patients is facilitated by the use of similar medicine and placebo. Neurologist and other researchers only have access to the serial number of the medicine box. The data analyzer has access to grouping but is still blind to the actual medicine and placebo information.
Placebo
Used
Assignment
Parallel
Other design features
Patients' diets do not change when they enter the study, and their routine medication administration do not stop
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-10-16, 1400/07/24
Ethics committee reference number
IR.IUMS.FMD.REC.1400.409
Health conditions studied
1
Description of health condition studied
Alzheimer's disease
ICD-10 code
G30.1
ICD-10 code description
Alzheimer's disease with late onset
Primary outcomes
1
Description
N-acetyl-aspartate (NAA) metabolite
Timepoint
Before and after the intervention (6 months)
Method of measurement
Part per million (ppm) in MR spectroscopy and percentage
2
Description
Amyloid beta-42 (Aβ42)
Timepoint
Before and after the intervention (6 months)
Method of measurement
ELISA kit
Secondary outcomes
1
Description
Low Density Lipoprotein Receptor-Related Protein-1 (LRP1)
Timepoint
Before and after the intervention (6 months)
Method of measurement
ELISA kit
2
Description
Lactate (Lac) metabolite
Timepoint
Before and after the intervention (6 months)
Method of measurement
Part per million (ppm) in MR spectroscopy and percentage
3
Description
Choline (Cho) metabolite
Timepoint
Before and after the intervention (6 months)
Method of measurement
Part per million (ppm) in MR spectroscopy and percentage
4
Description
Myoinositol (mI) metabolite
Timepoint
Before and after the intervention (6 months)
Method of measurement
Part per million (ppm) in MR spectroscopy and percentage
5
Description
Creatine (Cr) metabolite
Timepoint
Before and after the intervention (6 months)
Method of measurement
Part per million (ppm) in MR spectroscopy and percentage
6
Description
Correlation between imaging and blood biomarkers with clinical findings
Timepoint
Before and after the intervention (6 months)
Method of measurement
Percent with Pearson statistical test
7
Description
Mini-Mental State Exam (MMSE)
Timepoint
Before and after the intervention (6 months)
Method of measurement
MMSE questionnaire
8
Description
Clinical dementia rating (CDR)
Timepoint
Before and after the intervention (6 months)
Method of measurement
CDR questionnaire
9
Description
High density lipoprotein (HDL)
Timepoint
Before and after the intervention (6 months)
Method of measurement
Spectrophotometry
10
Description
Low density lipoprotein (LDL)
Timepoint
Before and after the intervention (6 months)
Method of measurement
Spectrophotometry
11
Description
Triglycerides (TG)
Timepoint
Before and after the intervention (6 months)
Method of measurement
Spectrophotometry
12
Description
Catalase (CAT)
Timepoint
Before and after the intervention (6 months)
Method of measurement
Spectrophotometry
13
Description
Superoxide dismutase (SOD)
Timepoint
Before and after the intervention (6 months)
Method of measurement
Spectrophotometry
14
Description
Malondialdehyde (MDA)
Timepoint
Before and after the intervention (6 months)
Method of measurement
Spectrophotometry
15
Description
Alanine aminotransferase (ALT)
Timepoint
Before and after the intervention (6 months)
Method of measurement
Spectrophotometry
16
Description
Aspartate aminotransferase (AST)
Timepoint
Before and after the intervention (6 months)
Method of measurement
Spectrophotometry
Intervention groups
1
Description
First intervention group: In addition to taking routine medications (10 mg Donepezil/6 mg Rivastigmine) once daily, patients receive 140 mg Silymarin tablets (Livergol 140 mg; Goldaru Pharmaceutical Company; Isfahan, Iran) orally three times daily with an interval of eight hours for 6 months.
Category
Treatment - Drugs
2
Description
Control group: In addition to taking routine medications (10 mg Donepezil/6 mg Rivastigmine) once daily, patients receive 140 mg placebo tablets (Livergol 140 mg; Goldaru Pharmaceutical Company; Isfahan, Iran) orally three times daily with an interval of eight hours for 6 months.
Category
Placebo
3
Description
Second intervention group: In addition to taking routine medications (10 mg Donepezil/6 mg Rivastigmine) once daily, patients receive 10 mg Rosuvastatin tablets (Ropixon 10 mg; Abidi Pharmaceutical Company; Tehran, Iran) orally three times daily with an interval of eight hours for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
Fatemeh Moradi
Street address
Qazvin St., Abuzar Square, 20 meters from Abuzar, Ziaeian Medical Center
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6814
Email
ziaeian@tums.ac.ir
2
Recruitment center
Name of recruitment center
Roozbeh Psychiatry Hospital
Full name of responsible person
Fatemeh Moradi
Street address
South Kargar Street, below Lashkar Crossroads, Roozbeh Psychiatric Hospital
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 9153
Email
hosp_roozbeh@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Moradi
Street address
Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Auob Rustamzadeh
Position
Ph.D. student in Anatomical Sciences
Latest degree
Master
Other areas of specialty/work
Anatomy
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Faculty of Medicine, Department of Anatomy
City
Tehran
Province
Tehran
Postal code
1449614525
Phone
+98 21 8670 4569
Email
auob2020rustamzade@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Moradi
Position
Associate Professor of Anatomical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Faculty of Medicine, Department of Anatomy
City
Tehran
Province
Tehran
Postal code
1449614525
Phone
+98 21 8670 4569
Email
f7moradi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Auob Rustamzadeh
Position
Ph.D. Student in Anatomical Sciences
Latest degree
Master
Other areas of specialty/work
Anatomy
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Faculty of Medicine, Department of Anatomy
City
Tehran
Province
Tehran
Postal code
1449614525
Phone
+98 21 8670 4569
Email
auob2020rustamzade@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