Detecting Beta-amyloid in the Retina

NCT07529912 | Terminated DMC

• 1 other identifier: 15/1253H/21
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia; Alzheimer Disease

Keywords

Hyperspectral imaging

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of hyperspectral retinal imaging for detection of Alzheimer's disease-related beta-amyloid

  Assessment of whether hyperspectral retinal imaging can distinguish participants with Alzheimer's disease from cognitively healthy controls based on retinal spectral reflectance signatures (particularly in the 480-520 nm wavelength range). Performance will be evaluated using quantitative image-derived biomarkers and classification accuracy (e.g., sensitivity, specificity, and area under the receiver operating characteristic curve) generated from computer-assisted image analysis.

  Single study visit (baseline imaging session; approximately 60 minutes)

Study Arms (1)

Detecting Beta-amyloid in the Retina

OTHER

Device: Hyperspectral camera

Interventions

Hyperspectral camera DEVICE

Hyperspectral imaging is performed with the Metabolic Hyperspectral Retinal Camera (Optina Diagnostic, Montreal, Canada) and a prototype camera developed by researchers at the Centre for Eye Research Australia (CERA). The Metabolic Hyperspectral Retinal Camera is similar to a typical fundus imager but it incorporates a tunable light source which is able to transmit safe light levels within a wavelength range covering the visible to near infrared with a narrow bandwidth (\< 3nm). This instrument is capable of imaging a 26° field-of-view of retina at 90 wavelengths in less than a second, thus minimizing discomfort and limiting the influence of eye movements. The hyperspectral camera developed by CERA researchers is a non-mydriatic fundus camera that uses light emitting diodes (LEDs) and an optical variable bandpass filter to tune the illumination wavelengths.

Detecting Beta-amyloid in the Retina

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for Eye Research Australia: lead

Study Sites (1)

The Centre for Eye Research Australia

Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: February 4, 2016
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

AU (1)