DementiaNCT07545473
Retinal Hyperspectral Imaging in Neurodegenerative Diseases
A study testing Hyperspectral camera in people with Dementia and Neurodegenerative Diseases, 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 a wealth of information about the 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, Neurodegenerative Diseases, 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
- 930 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Oct 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 over 30 years.
- 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).
- 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.
- 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.
- Be willing to participate in the study and attend the Centre for Eye Research Australia.
- Be accompanied by a friend or family member.
Who cannot join
- Inability to provide informed consent
- Ocular conditions preventing adequate retinal imaging (e.g., dense cataract, severe corneal opacity, vitreous haemorrhage)
- Known contraindication to pharmacological pupil dilation
- Any condition that, in the investigator's opinion, would compromise participant safety or image quality
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
The Centre for Eye Research Australia
Melbourne, Victoria, 3002
Darvy Dang, +61 3 9959 0102, darvy.dang@unimelb.edu
About this study
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 a wealth of information about the retinal structure. Our group has developed evidence supporting a role for this technology in the detection of retinal amyloid beta in Alzheimer's disease. We are undertaking further studies to establish the role of this method in the assessment of people with dementia, or those at risk of Alzheimer's disease. In addition, we wish to test whether the approach may have value in other forms of dementia or neurodegenerative disease such as Parkinson's disease, Lewy-Body dementia or vascular dementia.
Read the detailed description
The retina is the inner part of the eye that is developmentally linked to the brain. Taking specialised pictures of the retina of the eye can reveal information about a person's eye health as well as their general health. Several research studies have shown that there are subtle differences in the retinas of people with dementia or neurodegenerative diseases including Alzheimer's disease and Parkinson's disease, compared to those without the disease. For example, in Alzheimer's disease, a protein amyloid beta builds up in the brain and in the retina of the eye. The build up of amyloid beta corresponds with the stage of dementia. Currently, measuring amyloid beta requires an expensive test, known as a PET scan, that can be difficult to access and involves exposure to radiation, which means that it cannot be repeated often. The other way to measure amyloid beta levels involves a collection of fluid (cerebrospinal fluid) from around the spinal cord. The development of a cheap, quick and easy test to detect the level of amyloid deposits would be a major advance for not only people with Alzheimer's disease but other forms of dementia and neurodegenerative diseases. It may allow easier monitoring of the progression of the disease and, importantly, monitoring of the effectiveness of new treatments to slow progression of the disease. Different changes occur in the retina in other types of brain diseases, suggesting that eye scans may help to detect a range of different neurodegenerative diseases.
Over the past few years, our research group has been studying a new type of camera, known as a hyperspectral camera, that can take images of the retina using many different colours (wavelengths) of light. It provides us with very detailed information about the structure of the retina that we cannot get using standard cameras. The eye scan is safe, quick and easy. We have shown that the eye scan can provide valuable information about people's eye and brain health. We now aim to test whether the scans can be used to find changes in the retina that are linked with dementia or neurodegenerative diseases. If changes are found, this could be used in future to help detect dementia or neurodegenerative diseases in the early stages or to monitor disease progression.
- Conditions
- Dementia, Neurodegenerative Diseases, Alzheimer Disease, Parkinson Disease, Frontotemporal Dementia, Vascular Dementia
- Being tested
- Hyperspectral camera
- Keywords
- Hyperspectral imaging, Retina
- Medical subject headings
- Dementia, Neurodegenerative Diseases, Alzheimer Disease, Parkinson Disease, Frontotemporal Dementia, Dementia, Vascular, Lewy Body Disease, Niemann-Pick Diseases
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 |
|---|---|---|
| Hyperspectral camera | Experimental | 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. Receives: Device: Hyperspectral camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic classification of neurodegenerative diseases using hyperspectral retinal imaging
Evaluation of whether hyperspectral retinal imaging-derived biomarkers can distinguish between diagnostic groups including Alzheimer's disease, Lewy body dementia, Parkinson's disease, frontotemporal dementia, vascular dementia, and cognitively healthy controls. Diagnostic performance will be assessed using AI-based classification outputs, including sensitivity, specificity, classification accuracy, and area under the receiver operating characteristic curve (AUC).
Measured: During study visit (baseline data collection); analyses performed after completion of participant recruitment and imaging dataset acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start11 Oct 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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
- 930 participants (estimated)
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
- NCT07545473
- Sponsor's protocol ID
- 166/21
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 22 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Hyperspectral Imaging in Neurodegenerative Diseases
- ClinicalTrials.gov ID
- NCT07545473
- Acronym / sponsor ID
- 166/21
- Conditions
- Dementia, Neurodegenerative Diseases, Alzheimer Disease, Parkinson Disease, Frontotemporal Dementia, Vascular Dementia
- Keywords
- Hyperspectral imaging, Retina
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 930 participants (estimated)
- Lead sponsor
- Center for Eye Research AustraliaUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 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 a wealth of information about the retinal structure. Our group has developed evidence supporting a role for this technology in the detection of retinal amyloid beta in Alzheimer's disease. We are undertaking further studies to establish the role of this method in the assessment of people with dementia, or those at risk of Alzheimer's disease. In addition, we wish to test whether the approach may have value in other forms of dementia or neurodegenerative disease such as Parkinson's disease, Lewy-Body dementia or vascular dementia.
Detailed description
The retina is the inner part of the eye that is developmentally linked to the brain. Taking specialised pictures of the retina of the eye can reveal information about a person's eye health as well as their general health. Several research studies have shown that there are subtle differences in the retinas of people with dementia or neurodegenerative diseases including Alzheimer's disease and Parkinson's disease, compared to those without the disease. For example, in Alzheimer's disease, a protein amyloid beta builds up in the brain and in the retina of the eye. The build up of amyloid beta corresponds with the stage of dementia. Currently, measuring amyloid beta requires an expensive test, known as a PET scan, that can be difficult to access and involves exposure to radiation, which means that it cannot be repeated often. The other way to measure amyloid beta levels involves a collection of fluid (cerebrospinal fluid) from around the spinal cord. The development of a cheap, quick and easy test to detect the level of amyloid deposits would be a major advance for not only people with Alzheimer's disease but other forms of dementia and neurodegenerative diseases. It may allow easier monitoring of the progression of the disease and, importantly, monitoring of the effectiveness of new treatments to slow progression of the disease. Different changes occur in the retina in other types of brain diseases, suggesting that eye scans may help to detect a range of different neurodegenerative diseases.
Over the past few years, our research group has been studying a new type of camera, known as a hyperspectral camera, that can take images of the retina using many different colours (wavelengths) of light. It provides us with very detailed information about the structure of the retina that we cannot get using standard cameras. The eye scan is safe, quick and easy. We have shown that the eye scan can provide valuable information about people's eye and brain health. We now aim to test whether the scans can be used to find changes in the retina that are linked with dementia or neurodegenerative diseases. If changes are found, this could be used in future to help detect dementia or neurodegenerative diseases in the early stages or to monitor disease progression.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperspectral camera | Experimental | Device: 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged over 30 years.
- 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).
- 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.
- 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.
- Be willing to participate in the study and attend the Centre for Eye Research Australia.
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Ocular conditions preventing adequate retinal imaging (e.g., dense cataract, severe corneal opacity, vitreous haemorrhage)
- Known contraindication to pharmacological pupil dilation
- Any condition that, in the investigator's opinion, would compromise participant safety or image 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 | Hyperspectral camera |
Primary outcome
Diagnostic classification of neurodegenerative diseases using hyperspectral retinal imaging
Time frame: During study visit (baseline data collection); analyses performed after completion of participant recruitment and imaging dataset acquisition
Evaluation of whether hyperspectral retinal imaging-derived biomarkers can distinguish between diagnostic groups including Alzheimer's disease, Lewy body dementia, Parkinson's disease, frontotemporal dementia, vascular dementia, and cognitively healthy controls. Diagnostic performance will be assessed using AI-based classification outputs, including sensitivity, specificity, classification accuracy, and area under the receiver operating characteristic curve (AUC).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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.
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 Neurodegenerative Diseases, 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darvy Dang (+61 3 9959 0102, darvy.dang@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic classification of neurodegenerative diseases using hyperspectral retinal imaging (time frame: During study visit (baseline data collection); analyses performed after completion of participant recruitment and imaging dataset acquisition). 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 22 Apr 2026.