DementiaNCT07529912
Detecting Beta-amyloid in the Retina
A study testing Hyperspectral camera in people with Dementia and Alzheimer Disease, run by Center for Eye Research Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- Hyperspectral camera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Feb 2016to 9 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Centre for Eye Research Australia
Melbourne, Victoria, 3002
About this study
Official title: Non-invasive Retinal Imaging to Detect Beta-amyloid in Alzheimer's Disease
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.
Read the detailed description
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.
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- Hyperspectral camera
- Keywords
- Hyperspectral imaging
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperspectral cameraDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Detecting Beta-amyloid in the Retina | Other | Not described Receives: Device: Hyperspectral camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single study visit (baseline imaging session; approximately 60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start4 Feb 2016
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Why it stopped: This study has been transferred to the Human Research Ethics Committee of St Vincent's Hospital Melbourne.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Eye Research Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529912
- Sponsor's protocol ID
- 15/1253H/21
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Retinal Imaging to Detect Beta-amyloid in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07529912
- Acronym / sponsor ID
- 15/1253H/21
- Conditions
- Dementia, Alzheimer Disease
- Keywords
- Hyperspectral imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has been transferred to the Human Research Ethics Committee of St Vincent's Hospital Melbourne.
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Center for Eye Research AustraliaUniversity, hospital or other
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Detecting Beta-amyloid in the Retina | Other | Device: Hyperspectral camera |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperspectral cameraHyperspectral 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. | Device | Detecting Beta-amyloid in the Retina |
Primary outcome
Diagnostic performance of hyperspectral retinal imaging for detection of Alzheimer's disease-related beta-amyloid
Time frame: Single study visit (baseline imaging session; approximately 60 minutes)
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.
Results and safety
The study was stopped early (reason given: This study has been transferred to the Human Research Ethics Committee of St Vincent's Hospital Melbourne.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperspectral camera in people with Dementia and Alzheimer Disease, run by Center for Eye Research Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This study has been transferred to the Human Research Ethics Committee of St Vincent's Hospital Melbourne.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of hyperspectral retinal imaging for detection of Alzheimer's disease-related beta-amyloid (time frame: Single study visit (baseline imaging session; approximately 60 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.