This study has been transferred to the Human Research Ethics Committee of St Vincent's Hospital Melbourne.

Hyperspectral retinal imaging is a non-invasive imaging modality in which a series of images of the retina are captured using light of different wavelengths. The resulting "hypercube" of data provides detailed information about retinal structure. Previous research has demonstrated a potential role for this technology in the detection of retinal amyloid beta in Alzheimer's disease. This study aims to further evaluate the use of hyperspectral retinal imaging in the assessment of individuals with dementia or those at risk of Alzheimer's disease.

The study involves retinal imaging using specialised cameras to capture detailed photographs of the eye. Imaging includes the use of two hyperspectral retinal cameras, which are similar to standard retinal cameras but use multi-wavelength (multicoloured) light instead of a conventional white-light flash.

These hyperspectral imaging devices are investigational and are not approved for routine clinical use in Australia. Their use in this research has been approved by the Human Research Ethics Committee of the Royal Victorian Eye and Ear Hospital following scientific and ethical review. The Therapeutic Goods Administration of Australia has been notified of their use under the Clinical Trial Notification (CTN) scheme.

Inclusion Criteria:

• Aged 30 years and older
• Diagnosis of Alzheimer's disease or no evidence of Alzheimer's disease (including control participants or those with other neurodegenerative conditions such as Parkinson's disease, Lewy body dementia, or vascular dementia)
• Prior confirmation of Alzheimer's disease diagnosis by genetic testing or positron emission tomography (PET) scan (where applicable)
• Able to undergo cognitive assessment if required (for control participants without recent testing within the past 6 months)
• No major ocular conditions that would preclude retinal imaging
• Willing and able to attend the Royal Victorian Eye and Ear Hospital
• Able to attend with a friend or family member

Exclusion Criteria:

• Presence of significant ocular disease that prevents adequate retinal imaging
• Inability to undergo study procedures or comply with study requirements
• Any condition that, in the opinion of the investigators, would make participation unsafe or compromise data quality

The plan for sharing individual participant data (IPD) has not yet been finalised. This is a multi-modal imaging study involving large hyperspectral and ophthalmic imaging datasets, and decisions regarding data sharing will depend on completion of primary analyses, data governance requirements, and ethical approvals. The feasibility of appropriate de-identification and secure sharing mechanisms is under review.