ClinicalTrials.Veeva

Menu

OCT Angiography and NRAI in Dementia

Oregon Health & Science University (OHSU) logo

Oregon Health & Science University (OHSU)

Status

Enrolling

Conditions

Alzheimer Disease
Mild Cognitive Impairment
Dementia

Treatments

Device: Noninvasive Retinal Amyloid Imaging (NRAI)
Device: Optical Coherence Tomography Angiography (OCTA) Imaging

Study type

Observational

Funder types

Other

Identifiers

NCT03761381
IRB#00017045

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

20 participants in 2 patient groups

Early Dementia
Description:
This group will consist of adults with suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in one study visit.
Treatment:
Device: Noninvasive Retinal Amyloid Imaging (NRAI)
Device: Optical Coherence Tomography Angiography (OCTA) Imaging
Dementia-Free Controls
Description:
This group will consist of adults without suspected dementia/Alzheimer's Disease. OCTA and NRAI data will be gathered in one study visit.
Treatment:
Device: Noninvasive Retinal Amyloid Imaging (NRAI)
Device: Optical Coherence Tomography Angiography (OCTA) Imaging

Trial contacts and locations

1

Loading...

Central trial contact

Humberto Martinez, COT; Denzil Romfh, OD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems