Investigating the effect of nanocurcumin on brain volumetery and cognitive function of patients with Alzheimer’s disease-Interventional - Randomized controlled clinical trial
Investigating the effect of nanocurcumin on brain volumetery and cognitive function in patients with Alzheimer’s disease
Design
A randomized, double blinded ,and controlled clinical trial with 30 patients with Alzheimer’s disease who will be classified in a group receiving nanocurcumin and a group receiving placebo and followed for 6 months during 2026.
Settings and conduct
Patients with Alzheimer’s disease who diagnosed by a neurologist in Shiraz Emam Reza center or office enrolled based on inclusion criteria by a team member; then they receive nanocurcumin or placebo with double blind approach (patients and researchers) and will undergo brain MRI in Namazi hospital and perform cognitive test(MOCA) at the beginning of study and after 6 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients who diagnosed as 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.
Exclusion criteria:
Patients with other neurological conditions like Parkinson’s disease and stroke.
Use of anti inflammatory and antioxidants medications during study.
Any contraindications for MRI
Intervention groups
Some patients will take nanocurcumin and other patients will receive placebo
Main outcome variables
Brain volume alterations(volumetery based on MRI)cognitive function alterations(MoCA test)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231016059737N3
Registration date:2026-04-27, 1405/02/07
Registration timing:prospective
Last update:2026-04-27, 1405/02/07
Update count:0
Registration date
2026-04-27, 1405/02/07
Registrant information
Name
Vahid Reza Ostovan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 1065
Email address
ostovanv@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2026-08-23, 1405/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of nanocurcumin on brain volumetery and cognitive function of patients with Alzheimer’s disease-Interventional - Randomized controlled clinical trial
Public title
Investigating the effect of nanocurcumin on patients with Alzheimer’s disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Patients with other neurological diseases such as Parkinson’s disease, stroke
Use of anti-inflammatory or antioxidant medications
Any contraindications for MRI
Age
From 50 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medicine, Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2026-01-29, 1404/11/09
Ethics committee reference number
IR.SUMS.MED.REC.1404.588
Health conditions studied
1
Description of health condition studied
Alzheimer’s disease
ICD-10 code
G30.9
ICD-10 code description
Alzheimer's disease, unspecified
Primary outcomes
1
Description
Brain volume
Timepoint
Beginning of the study and after 6 months of intervention
Method of measurement
1.5Tesla structural MRI
2
Description
Cognitive function
Timepoint
At the beginning of study and after 6 months of intervention
Method of measurement
Montreal Cognitive Assessment (MoCA) test
Secondary outcomes
1
Description
Demographic factor(age)
Timepoint
At the beginning of study
Method of measurement
Based on date of birth
2
Description
Gender
Timepoint
At the beginning of study
Method of measurement
Inquiring about gender
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Imam Reza clinic
Full name of responsible person
Vahidreza OStovan
Street address
Imam Reza special and subspeciality, next to Namazi hospital, Namazi Square , Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3647 4313
Email
ostovanv@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Hamid Mohammadi
Street address
Research and Technology Deputy,7th Floor, Shiraz University of Medical Sciences Central Building, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Vahidreza ostovan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Neurology Department Office, Shahid Motazedi Educational and Medical Center, Namazi Square, Shiraz,Iran
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3612 1000
Email
ostovanv@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vahidreza Ostovan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Shahid Motari Educational and Medical Center, Namazi sq, Zand st.
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3612 1065
Email
Ostovanv@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vahidreza Ostovan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Shahid Motahari Center, Namazi sq, Zand street
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3612 1065
Email
ostovanv@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available