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Observational Study of OCT Angiography and NRAI in Dementia

This observational study aims to understand changes in the eyes of people with Alzheimer's disease, dementia, or mild cognitive impairment. Researchers will use two special imaging devices: Optical Coherence Tomography Angiography (OCTA) Imaging to look at blood vessels and blood flow in your eyes, and Noninvasive Retinal Amyloid Imaging (NRAI) to detect amyloid proteins, which are linked to Alzheimer's, in your eyes. The main goal is to see if these imaging techniques can detect amyloid protein in the retina. You might be able to join if you are over 55 and have a physician-confirmed diagnosis of probable Alzheimer's disease with mild dementia. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will observe and collect information without providing new treatments. It plans to include 20 participants.
What's involved
You would undergo Optical Coherence Tomography Angiography (OCTA) Imaging and Noninvasive Retinal Amyloid Imaging (NRAI). The primary endpoint is measured at 1 day.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 1 day, suggesting a short follow-up period.

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NCT03761381

OCT Angiography and NRAI in Dementia

Recruiting
Not specifiedAges 55+Observational
Oregon Health and Science University
~20 participants
Updated 2025-09-12 on ClinicalTrials.gov
What's tested:Optical Coherence Tomography Angiography (OCTA) ImagingNoninvasive Retinal Amyloid Imaging (NRAI)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Retinal amyloid protein detection
Measured over 1 day

Conditions

Alzheimer Disease
Dementia
Mild Cognitive Impairment

Explore related trials

Alzheimer's DiseaseDementiaMild cognitive disorder

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • David Huang, MD, PhD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University

Who to contact

Denzil Romfh, OD
[email protected]
503-494-4351
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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.

What this trial measures

  • Retinal amyloid protein detection1 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.