]>
IRCT20231016059737N3 IRCT 2026-04-27 Shiraz University of Medical Sciences Investigating the effect of nanocurcumin on patients with Alzheimer’s disease Investigating the effect of nanocurcumin on brain volumetery and cognitive function of patients with Alzheimer’s disease-Interventional - Randomized controlled clinical trial 2026-05-22 anticipated 30 Complete https://irct.ir/trial/89299 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are allocated with block randomization approach in quadruple blocks and considering two stratification factors including gender and severity of disease (mild and moderate). Medications are provided in similar codes and packaging to patients and researchers be unaware about the type of intervention(allocation concealment). A member of team who doesn’t contribute in randomization and intervention presenting, will select patients based on inclusion criteria, Blinding description: Participants, medical team members and researchers are blind about type of intervention (Curcumin vs Placebo). capsules of Curcumin and Placebo are completely similar in shape, color, taste and odor. Also, Data analysts are blind at groups allocation to prevent the biases in results. 2-3 Alzheimer’s disease. Intervention 1: Intervention group: patients with Alzheimer’s disease who will receive nanocurcumin soft gel (exirnanosina pharmaceutical company)at a dose of 40 mg per day for six months. Intervention 2: Control group: patients with Alzheimer’s disease who will receive one soft gel of placebo per (similar to nanucorcumin in shape, size and color ) per day for six months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There are not more data
public Vahidreza ostovan
Neurology Department Office, Shahid Motazedi Educational and Medical Center, Namazi Square, Shiraz,Iran
Shiraz Iran (Islamic Republic of) 71348714737 +98 71 3612 1000 ostovanv@gmail.com Shiraz University of Medical Sciences scientific Vahidreza Ostovan
Shahid Motari Educational and Medical Center, Namazi sq, Zand st.
Shiraz Iran (Islamic Republic of) 71348714737 +98 71 3612 1065 Ostovanv@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with mild or moderate Alzheimer’s disease based on DSM-5 and NIA-AA 50-85 years old patients Ability to do cognitive tests and MRI 50 years 85 years Both Patients with other neurological diseases such as Parkinson’s disease, stroke Use of anti-inflammatory or antioxidant medications Any contraindications for MRI G30.9 Alzheimer's disease, unspecified Treatment - Drugs Placebo Intervention group: patients with Alzheimer’s disease who will receive nanocurcumin soft gel (exirnanosina pharmaceutical company)at a dose of 40 mg per day for six months. Control group: patients with Alzheimer’s disease who will receive one soft gel of placebo per (similar to nanucorcumin in shape, size and color ) per day for six months. Brain volume. Timepoint: Beginning of the study and after 6 months of intervention. Method of measurement: 1.5Tesla structural MRI. Cognitive function. Timepoint: At the beginning of study and after 6 months of intervention. Method of measurement: Montreal Cognitive Assessment (MoCA) test. Demographic factor(age). Timepoint: At the beginning of study. Method of measurement: Based on date of birth. Gender. Timepoint: At the beginning of study. Method of measurement: Inquiring about gender. Shiraz University of Medical Sciences Approved 2026-01-29 Ethics Committee of the Faculty of Medicine, Shiraz University of Medical Sciences Zand street Shiraz Fars Iran (Islamic Republic of)