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IRCT20210901052360N1 IRCT 2021-10-26 Iran University of Medical Sciences The effect of Silymarin on dyslipidemic patients with Alzheimer's disease Clinical trial of the effect of Silymarin on blood and imaging biomarkers of Alzheimer's patients with dyslipidemia 2021-10-25 anticipated 36 Complete https://irct.ir/trial/59485 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients' diets do not change when they enter the study, and their routine medication administration do not stop, 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 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. 3 Alzheimer's disease. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Auob Rustamzadeh
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Faculty of Medicine, Department of Anatomy
Tehran Iran (Islamic Republic of) 1449614525 +98 21 8670 4569 auob2020rustamzade@gmail.com Iran University of Medical Sciences scientific Fatemeh Moradi
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Faculty of Medicine, Department of Anatomy
Tehran Iran (Islamic Republic of) 1449614525 +98 21 8670 4569 f7moradi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 60 years 80 years Both 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. G30.1 Alzheimer's disease with late onset Treatment - Drugs Placebo Treatment - Drugs 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. 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. 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. 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. Amyloid beta-42 (Aβ42). Timepoint: Before and after the intervention (6 months). Method of measurement: ELISA kit. Low Density Lipoprotein Receptor-Related Protein-1 (LRP1). Timepoint: Before and after the intervention (6 months). Method of measurement: ELISA kit. Lactate (Lac) metabolite. Timepoint: Before and after the intervention (6 months). Method of measurement: Part per million (ppm) in MR spectroscopy and percentage. Choline (Cho) metabolite. Timepoint: Before and after the intervention (6 months). Method of measurement: Part per million (ppm) in MR spectroscopy and percentage. Myoinositol (mI) metabolite. Timepoint: Before and after the intervention (6 months). Method of measurement: Part per million (ppm) in MR spectroscopy and percentage. Creatine (Cr) metabolite. Timepoint: Before and after the intervention (6 months). Method of measurement: Part per million (ppm) in MR spectroscopy and percentage. 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. Mini-Mental State Exam (MMSE). Timepoint: Before and after the intervention (6 months). Method of measurement: MMSE questionnaire. Clinical dementia rating (CDR). Timepoint: Before and after the intervention (6 months). Method of measurement: CDR questionnaire. High density lipoprotein (HDL). Timepoint: Before and after the intervention (6 months). Method of measurement: Spectrophotometry. Low density lipoprotein (LDL). Timepoint: Before and after the intervention (6 months). Method of measurement: Spectrophotometry. Triglycerides (TG). Timepoint: Before and after the intervention (6 months). Method of measurement: Spectrophotometry. Catalase (CAT). Timepoint: Before and after the intervention (6 months). Method of measurement: Spectrophotometry. Superoxide dismutase (SOD). Timepoint: Before and after the intervention (6 months). Method of measurement: Spectrophotometry. Malondialdehyde (MDA). Timepoint: Before and after the intervention (6 months). Method of measurement: Spectrophotometry. Alanine aminotransferase (ALT). Timepoint: Before and after the intervention (6 months). Method of measurement: Spectrophotometry. Aspartate aminotransferase (AST). Timepoint: Before and after the intervention (6 months). Method of measurement: Spectrophotometry. Iran University of Medical Sciences Approved 2021-10-16 Ethics Committee of Iran University of Medical Sciences Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)