ClinicalTrials.gov record NCT07545473

Retinal Hyperspectral Imaging in Neurodegenerative Diseases

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Retinal Hyperspectral Imaging in Neurodegenerative Diseases

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age30 years old and older
SexAll
LocationAustralia
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study uses hyperspectral retinal cameras to take detailed, non-invasive eye images from people with dementia or other neurodegenerative diseases and from age-matched controls. Two devices are used: the Metabolic Hyperspectral Retinal Camera (Optina) and a CERA prototype; images will be analyzed, including with AI-based classification. The study aims to see if image-derived biomarkers can distinguish different diagnostic groups.

What it is studying. Whether hyperspectral retinal imaging can identify retinal signs (including retinal amyloid beta noted in Alzheimer's disease) linked to dementia and other neurodegenerative diseases, and whether imaging-derived biomarkers can be used to classify diagnostic groups using AI-based analysis.

What the researchers hope to learn. To evaluate whether hyperspectral retinal imaging-derived biomarkers can distinguish Alzheimer's disease, Lewy body dementia, Parkinson's disease, frontotemporal dementia, vascular dementia, and cognitively healthy controls; and to assess AI-based diagnostic performance measures such as sensitivity, specificity, accuracy, and AUC.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device
  • Hyperspectral camera

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Attend a study visit for non‑invasive hyperspectral retinal imaging using a specialised camera. The scan captures many wavelengths of light in a brief image; some people may require pharmacological pupil dilation unless contraindicated. You must be able to give informed consent and come with a friend or family member. Images are collected at the baseline visit and later analysed (the registry does not list other procedures).

How the study is structured. Interventional, single-group, non-masked device study. Participants undergo non-invasive hyperspectral retinal imaging with the Optina Metabolic camera and a Centre for Eye Research Australia prototype; images are collected during a study visit and later analyzed (including AI-based classification) to evaluate diagnostic performance.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Australia. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Niemann-Pick disease type C

Clinical trials15 trials listed for Niemann-Pick disease type CEvery trial the registry lists for Niemann-Pick disease type C, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Niemann-Pick disease type C researchLatest monthly update: September 2026. Includes: Gene change range. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 11, 2021
Primary completion
Dec 31, 2028 (estimated)
Study completion
Dec 31, 2028 (estimated)
Target enrollment
930 participants (estimated)
Last updated on registry
Apr 22, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Center for Eye Research Australia

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

biomarker
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
PET scan
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
contraindication
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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