OCT Angiography and NRAI in Dementia

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: Recruiting
• Conditions: Dementia; Alzheimer Disease; Mild Cognitive Impairment
• Intervention / Treatment: Device: Optical Coherence Tomography Angiography (OCTA) Imaging; Device: Noninvasive Retinal Amyloid Imaging (NRAI)

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Humberto Martinez, COT; Phone Number: 503-494-7712; Email: martinhu@ohsu.edu
• Study Contact Backup: Name: Denzil Romfh, OD; Phone Number: 503-494-4351; Email: romfhd@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Humberto Martinez, COT; Phone Number: 503-494-7712; Email: martinhu@ohsu.edu
      • Contact: Denzil Romfh, OD; Phone Number: 503-494-4351; Email: romfhd@ohsu.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 day

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: David Huang, MD, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: OCT; MCI; Dementia; Alzheimer's; Angiography
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease; Dementia; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Radiography
• Other Study ID 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