Alzheimer DiseaseNCT03761381
OCT Angiography and NRAI in Dementia
An observational study of Alzheimer Disease and Dementia, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to: 1. Detect retinal blood vessel and blood flow changes in participants with dementia. 2. Detect amyloid protein deposits in the retinas of participants with dementia. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Mild Cognitive Impairment
- What is being tested?
- Optical Coherence Tomography Angiography (OCTA) Imaging and Noninvasive Retinal Amyloid Imaging (NRAI)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2018to Dec 2027
- Phase
- Observational
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dementia subjects will be recruited from the Layton Aging \& Alzheimer's Disease Clinic at Oregon Health \& Science University. Dementia-free subjects will be recruited from those currently being followed in the Layton Aging \& Alzheimer's Disease Center longitudinal aging study with MRI and amyloid PET imaging.
Who may be able to join
- Physician-confirmed diagnosis of probable Alzheimer's disease
- Mild dementia, as defined by score of 20 or greater on the Mini-Mental State Exam, or score of 15 or greater on the Montreal Cognitive Assessment, or Clinical Dementia Rating Scale score of 1.
- Age older than 55 years.
- Able to comply with study procedures
- Corrected visual acuity at least 20/400 in either eye.
- Has a legally authorized representative who can sign study consent form and accompany the participant to the OCT study visit.
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- Age older than 55 years
- Able to comply with study procedures
- Able to maintain stable fixation for OCT imaging
- Corrected visual acuity of at least 20/40 in either eye
- Dementia-free, as defined by score of 24 or greater on the Mini-Mental Status Exam, or a score of 18 or greater on the Montreal Cognitive Assessment, or Clinical Dementia Rating of <1.0.
- Exclusion Criteria for both dementia and dementia-free subjects:
- Non-Alzheimer's disease related primary neurologic disease affecting the central nervous system (i.e. multiple sclerosis, Parkinson's disease)
- Evidence on ophthalmological exam within the last year of other ocular diseases or pathology that would confound the assessment of dementia (e.g. glaucoma, diabetic or hypertensive retinal disease, amblyopia, etc.)
- Media opacity such as cataract, corneal scar, or vitreous opacity that could interfere with retinal imaging.
- Previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber intraocular lens implantation
- Inability to maintain stable fixation for OCT imaging or provide informed consent
- Spherical equivalent refractive error greater than +3 or -7 diopters, or astigmatism magnitude of greater than 2 diopters.
- Diabetes for more than 10 years or hemoglobin A1C level of > 10 within the 180 days prior to OCT scanning.
- Uncontrolled hypertension. : SBP > 170 or DBP > 100
- Arrhythmia: irregular pulse, or heart rate not between 50 and 110 beats per minute
- Pregnancy or breast feeding.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Denzil Romfh, OD, 503-494-4351, romfhd@ohsu.edu
Humberto Martinez, COT, 503-494-7712, martinhu@ohsu.edu
About this study
Official title: Using Optical Coherence Tomography and Noninvasive Retinal Amyloid Imaging to Capture Retinal Changes Associated With Dementia
The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to:
- Detect retinal blood vessel and blood flow changes in participants with dementia.
- Detect amyloid protein deposits in the retinas of participants with dementia.
- Conditions
- Alzheimer Disease, Dementia, Mild Cognitive Impairment
- Being tested
- Optical Coherence Tomography Angiography (OCTA) Imaging, Noninvasive Retinal Amyloid Imaging (NRAI)
- Keywords
- MCI, OCT, Angiography, Alzheimer's, Dementia
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography Angiography (OCTA) ImagingDevice
Optical coherence tomography is a non-invasive imaging technology that provides cross-sectional images of tissues in micron-scale resolution. The angiography component of this device allows for evaluation of blood vessel and blood flow changes in the eye. The Solix device with AngioVue software will be used to detect these blood vessel and flow changes as well as protein deposits in the retinal layers.
Noninvasive Retinal Amyloid Imaging (NRAI)Device
The Spectralis will be used for NRAI. This system uses a special light source and optical filters to detect fluorescence of amyloid proteins in the eye.
| Study group | Role | What they receive |
|---|---|---|
| Early Dementia | This group will consist of adults with suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in one study visit. Receives: Device: Optical Coherence Tomography Angiography (OCTA) Imaging; Device: Noninvasive Retinal Amyloid Imaging (NRAI) | |
| Dementia-Free Controls | This group will consist of adults without suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in one study visit. Receives: Device: Optical Coherence Tomography Angiography (OCTA) Imaging; Device: Noninvasive Retinal Amyloid Imaging (NRAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal amyloid protein detection
OCT and OCT angiography will be used to detect levels of amyloid proteins deposits within the retina layers on the single enrollment visit only. An increase in the protein detection is expected in the dementia group.
Measured: 1 day
Secondary outcomes (2)
Decreased blood flow
OCT and OCT angiography will be used to detect blood flow in dementia vs dementia-free controls. OCT and OCTA imaging will be taken on the single enrollment visit only. Decreased blood flow is expected in the dementia group.
Measured: 1 day
Decreased retinal perfusion
OCT and OCT angiography will be used to detect retinal perfusion deficits in dementia vs dementia-free controls. OCT and OCTA imaging will be taken on a single enrollment visit only. Decreased retinal perfusion is expected in the dementia group.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start14 Sep 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- David Huang, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761381
- Sponsor's protocol ID
- IRB#00017045
- Status last verified
- Sep 2025
- First submitted
- 2 Jul 2018
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Optical Coherence Tomography and Noninvasive Retinal Amyloid Imaging to Capture Retinal Changes Associated With Dementia
- ClinicalTrials.gov ID
- NCT03761381
- Acronym / sponsor ID
- IRB#00017045
- Conditions
- Alzheimer Disease, Dementia, Mild Cognitive Impairment
- Keywords
- MCI, OCT, Angiography, Alzheimer's, Dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Dec 2018 (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.
The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to:
- Detect retinal blood vessel and blood flow changes in participants with dementia.
- Detect amyloid protein deposits in the retinas of participants with dementia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Dementia | – | Device: Optical Coherence Tomography Angiography (OCTA) Imaging, Device: Noninvasive Retinal Amyloid Imaging (NRAI)This group will consist of adults with suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in one study visit. |
| Dementia-Free Controls | – | Device: Optical Coherence Tomography Angiography (OCTA) Imaging, Device: Noninvasive Retinal Amyloid Imaging (NRAI)This group will consist of adults without suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in one study visit. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dementia subjects will be recruited from the Layton Aging \& Alzheimer's Disease Clinic at Oregon Health \& Science University. Dementia-free subjects will be recruited from those currently being followed in the Layton Aging \& Alzheimer's Disease Center longitudinal aging study with MRI and amyloid PET imaging.
Key inclusion criteria (22 listed)
- Physician-confirmed diagnosis of probable Alzheimer's disease
- Mild dementia, as defined by score of 20 or greater on the Mini-Mental State Exam, or score of 15 or greater on the Montreal Cognitive Assessment, or Clinical Dementia Rating Scale score of 1.
- Age older than 55 years.
- Able to comply with study procedures
- Corrected visual acuity at least 20/400 in either eye.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Optical Coherence Tomography Angiography (OCTA) ImagingOptical coherence tomography is a non-invasive imaging technology that provides cross-sectional images of tissues in micron-scale resolution. The angiography component of this device allows for evaluation of blood vessel and blood flow changes in the eye. The Solix device with AngioVue software will be used to detect these blood vessel and flow changes as well as protein deposits in the retinal layers. | Device | Dementia-Free Controls, Early Dementia |
| Noninvasive Retinal Amyloid Imaging (NRAI)The Spectralis will be used for NRAI. This system uses a special light source and optical filters to detect fluorescence of amyloid proteins in the eye. | Device | Dementia-Free Controls, Early Dementia |
Primary outcome
Retinal amyloid protein detection
Time frame: 1 day
OCT and OCT angiography will be used to detect levels of amyloid proteins deposits within the retina layers on the single enrollment visit only. An increase in the protein detection is expected in the dementia group.
2 secondary outcomes
Decreased blood flow
Time frame: 1 day
Decreased retinal perfusion
Time frame: 1 day
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 12 Sep 2025.
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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.
David Huang, MD, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia, run by Oregon Health and Science University at 1 site in United States.
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 22 inclusion and 0 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 12 Sep 2025. 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 United States. 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 Denzil Romfh, OD (503-494-4351, romfhd@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal amyloid protein detection (time frame: 1 day). 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 12 Sep 2025.