Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000971336
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
19/07/2026
Date registered
Help: Date registered
7/08/2026
Date last updated
Help: Date last updated
7/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
7/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Thoracic aortic inflammation in people undergoing brain Positron Emission Tomography (PET) scans for suspected Alzheimer's disease.
Scientific title
Imaging the Inflammatory Axis in People with Suspected Alzheimer's Disease: A Prospective Observational Study of Thoracic Aortic Inflammation Using Fluorine-18 Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (18F-FDG PET/CT)
Additional trial identifiers [1] 317953 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Alzheimer's disease 342916 0
Condition category
Condition code
Neurological 339035 339035 0 0
Alzheimer's disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
Participants referred for clinically indicated brain 18F-FDG PET/CT for suspected Alzheimer's disease will undergo an additional low-dose thoracic PET/CT acquisition during the same imaging session, without additional administration of 18F-FDG. The routine brain PET/CT acquisition is approximately 20 minutes, followed by an additional low-dose thoracic PET/CT acquisition of approximately 5–10 minutes, resulting in a total PET/CT imaging time of approximately 25–30 minutes. Thoracic aortic FDG uptake will be quantified and correlated with cerebral FDG PET metabolic patterns, cognitive assessment (MMSE and/or MoCA), and clinical diagnosis. No experimental treatment or change to routine clinical management will occur as part of the study.
Intervention code [1] 334820 0
Diagnosis / Prognosis
Description of the comparator or control
No control group. This is a single-arm prospective observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346277 0
Thoracic aortic inflammation
Timepoint [1] 346277 0
At the baseline PET/CT assessment (single study visit).
Primary outcome [2] 346345 0
Cerebral glucose hypometabolism
Timepoint [2] 346345 0
At the baseline PET/CT assessment (single study visit).
Secondary outcome [1] 465297 0
Cognitive performance
Timepoint [1] 465297 0
At the baseline clinical assessment as part of the routine diagnostic work-up.
Secondary outcome [2] 465298 0
Final clinical diagnostic classification of cognitive impairment
Timepoint [2] 465298 0
At completion of the routine diagnostic work-up, when the final clinical diagnostic classification is documented by the treating clinician.

Eligibility
Key inclusion criteria
Adults aged 50 years or older with suspected Alzheimer's disease referred for clinically indicated FDG PET/CT brain imaging, able and willing to provide written informed consent, MMSE greater than or equal to 21 (or equivalent), able to tolerate PET/CT imaging, and willing to undergo an additional research thoracic FDG PET/low-dose CT acquisition.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Prior diagnosis of frontotemporal dementia, vascular dementia, dementia with Lewy bodies, or other non-Alzheimer neurodegenerative disorders; history of stroke, transient ischaemic attack, or significant structural brain pathology; severe cognitive impairment preventing consent; active malignancy or other condition causing increased systemic FDG uptake; poorly controlled diabetes (blood glucose >11 mmol/L at the time of scan); contraindication to FDG PET/CT (including pregnancy or inability to lie supine); participation in another interventional study affecting PET outcomes; or previous FDG PET/CT for cognitive impairment within the past 12 months.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will summarise participant characteristics. Associations between thoracic aortic FDG uptake parameters and regional brain FDG PET metabolic measures, cognitive scores (MMSE and MoCA), and clinical diagnosis will be assessed using correlation and regression analyses. Appropriate parametric or non-parametric statistical tests will be used depending on data distribution, with statistical significance set at p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/08/2026
Actual
Date of last participant enrolment
Anticipated
30/04/2028
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 29881 0
South Perth Hospital - South Perth
Recruitment postcode(s) [1] 46237 0
6151 - South Perth

Funding & Sponsors
Funding source category [1] 322502 0
University
Name [1] 322502 0
Harry Perkins Institute of Medical Research – In-kind Cardiovascular Imaging Research Support (Professor Girish Dwivedi Discretionary Fund)
Country [1] 322502 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 325423 0
None
Name [1] 325423 0
Address [1] 325423 0
Country [1] 325423 0
Other collaborator category [1] 284044 0
University
Name [1] 284044 0
Harry Perkins Institute of Medical Research
Address [1] 284044 0
Country [1] 284044 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320986 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 320986 0
Ethics committee country [1] 320986 0
Australia
Date submitted for ethics approval [1] 320986 0
05/02/2026
Approval date [1] 320986 0
17/06/2026
Ethics approval number [1] 320986 0
2025/ET001162

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

Contacts
Principal investigator
Name 152278 0
Dr Shipra Verma
Address 152278 0
The University of Western Australia 35 Stirling Highway Crawley WA 6009 Australia
Country 152278 0
Australia
Phone 152278 0
+61 8 6152 2222
Fax 152278 0
Email 152278 0
[email protected]
Contact person for public queries
Name 152279 0
Shipra Verma
Address 152279 0
The University of Western Australia 35 Stirling Highway Crawley WA 6009 Australia
Country 152279 0
Australia
Phone 152279 0
+61 8 6152 2222
Fax 152279 0
Email 152279 0
[email protected]
Contact person for scientific queries
Name 152280 0
Shipra Verma
Address 152280 0
The University of Western Australia 35 Stirling Highway Crawley WA 6009 Australia
Country 152280 0
Australia
Phone 152280 0
+61 8 6152 2222
Fax 152280 0
Email 152280 0
[email protected]

Data sharing statement
Will the study consider sharing 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.