Hyperspectral retinal imaging to detect Alzheimer’s and other neurodegenerative changes

Retinal Hyperspectral Imaging in Neurodegenerative Diseases

This project will test whether a special retinal camera that scans many wavelengths of light can detect signs of Alzheimer’s and other neurodegenerative diseases in people with dementia or at risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 930 (estimated)
• Ages: 30 Years and up
• Sex: All
• Sponsor: Center for Eye Research Australia (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT07545473 on ClinicalTrials.gov

What this trial studies

This interventional imaging project uses non-invasive hyperspectral retinal photography to capture a multidimensional "hypercube" of retinal data that may reflect underlying brain protein changes such as amyloid beta. Participants will include people over 30 with Alzheimer’s disease, Parkinson’s disease, Lewy-body dementia, vascular dementia, other neurodegenerative conditions, and age- and sex-matched controls who will undergo retinal imaging with a hyperspectral camera. Where available, prior diagnostic data (genetic tests, blood biomarkers, amyloid PET, or cerebrospinal fluid results) will be used to compare retinal signatures against established biomarkers. The study aims to expand prior findings of retinal amyloid signals in Alzheimer’s to see if similar retinal changes appear across other dementias and neurodegenerative diseases.

Who should consider this trial

Good fit: Adults over 30 with a diagnosed dementia or neurodegenerative disease (including Alzheimer’s, Parkinson’s, Lewy-body, Niemann-Pick type 2, or vascular dementia) or age- and sex-matched controls, who generally have prior confirmatory testing (genetic, blood biomarkers, PET, or CSF except for typical Parkinson’s and Lewy-body cases) and sufficient corrected vision without major ocular disease.

Not a fit: People with very poor vision or advanced eye disease (for example advanced age-related macular degeneration or advanced glaucoma) or those unable to attend the Melbourne imaging site are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could provide a quick, inexpensive, non-invasive way to screen for and monitor protein-related changes linked to Alzheimer’s and other neurodegenerative diseases.

How similar studies have performed: Previous work, including results from this group, has shown promising evidence that hyperspectral retinal imaging can detect retinal amyloid beta in Alzheimer’s disease, but its application across other dementias is less established.

Eligibility criteria

Inclusion Criteria:

1. Aged over 30 years.
2. Have dementia or a neurodegenerative disease such as Alzheimer's disease, Parkinson's disease, Lewy body dementia, Niemann-Pick type 2 or vascular dementia (age-matched and sex-matched controls will also be recruited).
3. With the exception of participants with Parkinson's disease and Lewy body disease, for whom clinical examination by a neurologist is sufficient to establish a clinical diagnosis of probable dementia with Lewy Body or probable Parkinson disease dementia, all participants must have previously undergone at least of one of the following tests to help to confirm a clinical diagnosis of dementia or neurodegenerative disease: genetic tests, blood biomarker tests (amyloid, tau, neurofilament light), a brain amyloid beta PET scan, or cerebrospinal fluid tests.
4. Have a minimum best corrected visual acuity level of 6/60 in both eyes and no major eye problems, such as advanced age-related macular degeneration, advanced glaucoma, or greater than moderate non-proliferative diabetic retinopathy.
5. Be willing to participate in the study and attend the Centre for Eye Research Australia.
6. Be accompanied by a friend or family member.

Exclusion Criteria:

1. Inability to provide informed consent
2. Ocular conditions preventing adequate retinal imaging (e.g., dense cataract, severe corneal opacity, vitreous haemorrhage)
3. Known contraindication to pharmacological pupil dilation
4. Any condition that, in the investigator's opinion, would compromise participant safety or image quality

Where this trial is running

Melbourne, Victoria

• The Centre for Eye Research Australia — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Darvy Dang

Conditions Dementia; Neurodegenerative Diseases; Alzheimer Disease; Parkinson Disease; Frontotemporal Dementia; Vascular Dementia; Lewy Body Disease; Niemann-Pick Diseases