OCT Angiography and NRAI in Dementia

September 5, 2025 updated by: David Huang, Oregon Health and Science University

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:

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria for dementia subjects:

  • 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.

Inclusion Criteria for dementia-free controls:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Optical Coherence Tomography Angiography (OCTA) Imaging
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.
Device: 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.
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.
Device: Optical Coherence Tomography Angiography (OCTA) Imaging
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Decreased blood flow
Time Frame: 1 day
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.
1 day
Decreased retinal perfusion
Time Frame: 1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Huang, MD, PhD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB#00017045

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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