Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000843358p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
26/06/2026
Date registered
Help: Date registered
13/07/2026
Date last updated
Help: Date last updated
13/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
13/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Screening and Prevention of Alzheimer's Disease Using Magnetic Resonance Imaging Biomarker and Milk Supplements in Ageing Population
Scientific title
Entorhinal Cortex as Imaging Biomarker for Screening and Prevention of Alzheimer’s Disease Using Milk Supplement Lactoferrin in Ageing Population
Additional trial identifiers [1] 317702 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Alzheimer's disease 342553 0
Ageing 342600 0
Condition category
Condition code
Neurological 338739 338739 0 0
Studies of the normal brain and nervous system
Neurological 338744 338744 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
What is the intervention:
15 participants whose MRI images show above threshold structural changes of entorhinal cortex will take self-administered lactoferrin milk supplement tablets daily (200mg per day) for 10 months.
Who delivers it and their relevant expertise:
The Chief Investigator will purchase lactoferrin tablets from pharmacy shops such as Chemist Warehouse and distribute them to the participants. The CI is an experienced researcher at Charles Sturt University who has completed several major research projects successfully including phase I MRI imaging biomarker clinical trial on which this phase II study is based.
How it is delivered:
The lactoferrin tablets will be delivered to the participants face to face. Participants will take the tablets daily at their own home.
How often and for how long:
The selected participants will take daily lactoferrin supplements (200mg per day) for 10 months.
Where it is delivered:
The selected participants will take daily lactoferrin tablets at their own home.
Adherence:
The Chief Investigator will communicate with the participants monthly via email in monitoring the the progress.
Intervention code [1] 334550 0
Early detection / Screening
Intervention code [2] 334551 0
Prevention
Intervention code [3] 334552 0
Treatment: Other
Description of the comparator or control
What is the comparator:
The participants act as their own control..
Who delivers it and their relevant expertise:
The participants' baseline MRI images will be acquired at Monash National Imaging Facility by highly qualified MRI technologists.
How it is delivered:
The participants will travel to Monash Imaging Facility for their MRI imaging.
How often and for how long:
The MRI scan will take about 30 mins. The selected participants will take a second MRI scan 10 months after their first baseline MRI scan.
Where it is delivered:
The MRI scans will take place at Monash National Imaging Facility.
Adherence:
The participants will be notified their scheduled MRI scans via emails.
Control group
Active

Outcomes
Primary outcome [1] 345952 0
Accuracy of entorhinal cortex imaging as a biomarker for identifying early Alzheimer's disease.
Timepoint [1] 345952 0
Baseline MRI scans will take place immediately after enrollment.
Primary outcome [2] 346166 0
Change in Alzheimer's disease progression following lactoferrin supplementation.
Timepoint [2] 346166 0
Baseline MRI scans and 10 months post baseline MRI scans.
Secondary outcome [1] 464468 0
Changes in microstructures of entorhinal cortex following lactoferrin supplementation.
Timepoint [1] 464468 0
First baseline MRI scans immediately after enrollment and second MRI scans 10 months after the first MRI scans.

Eligibility
Key inclusion criteria
•Aged between 50 and 80.
•Without Alzheimer's disease diagnosis.
•Living in Melbourne.
•Free to travel to the Biomedical Imaging Facility of Monash University.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Suffered from claustrophobia as participants will confined within a small space for 30 mins during MRI scans.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322244 0
Commercial sector/Industry
Name [1] 322244 0
Stainlesspro Pty Ltd
Country [1] 322244 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
Country
Australia
Secondary sponsor category [1] 325154 0
None
Name [1] 325154 0
Address [1] 325154 0
Country [1] 325154 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 320768 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [1] 320768 0
Ethics committee country [1] 320768 0
Australia
Date submitted for ethics approval [1] 320768 0
17/07/2026
Approval date [1] 320768 0
Ethics approval number [1] 320768 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151550 0
Dr Xiaoming Zheng
Address 151550 0
School of Dentistry and Medical Sciences, Charles Sturt University, Wagga Wagga, NSW 2678
Country 151550 0
Australia
Phone 151550 0
+61269332068
Fax 151550 0
Email 151550 0
[email protected]
Contact person for public queries
Name 151551 0
Xiaoming Zheng
Address 151551 0
School of Dentistry and Medical Sciences, Charles Sturt University, Wagga Wagga, NSW 2678
Country 151551 0
Australia
Phone 151551 0
+61269332068
Fax 151551 0
Email 151551 0
[email protected]
Contact person for scientific queries
Name 151552 0
Xiaoming Zheng
Address 151552 0
School of Dentistry and Medical Sciences, Charles Sturt University, Wagga Wagga, NSW 2678
Country 151552 0
Australia
Phone 151552 0
+61269332068
Fax 151552 0
Email 151552 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.