Recruiting

OCT & NRAI

Sponsor:

Oregon Health and Science University

Code:

NCT03761381

Conditions

Alzheimer Disease

Dementia

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

Optical Coherence Tomography Angiography (OCTA) Imaging

Noninvasive Retinal Amyloid Imaging (NRAI)

Study Details

Brief 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.

Conditions

Alzheimer Disease

Dementia

Mild Cognitive Impairment

Study ID

NCT03761381

Start date

Sep 14, 2018

Status verified date

Sep, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Retinal amyloid protein detection [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Denzil Romfh, OD

503-494-4351romfhd@ohsu.edu

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Denzil Romfh, OD

503-494-4351romfhd@ohsu.edu

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Keywords

  • MCI
  • OCT
  • Angiography
  • Alzheimer's
  • Dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-09-12.