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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210901052360N1
Enrollment
36
Registered
2021-10-26
Start date
2021-10-25
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's disease. Alzheimer's disease with late onset

Interventions

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
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 Rivasti
Abidi Pharmaceutical Company
Tehran, Iran) orally three times daily with an interval of eight hours for 6 months.

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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 (Aß42). Timepoint: Before and after the intervention (6 months). Method of measurement: ELISA kit.

Secondary

MeasureTime frame
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: Spectrophoto

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAuob Rustamzadeh

Iran University of Medical Sciences

auob2020rustamzade@gmail.com+98 21 8670 4569

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026