NCT03761381Recruiting
OCT Angiography and NRAI in Dementia
Using Optical Coherence Tomography and Noninvasive Retinal Amyloid Imaging to Capture Retinal Changes Associated With Dementia
Source: ClinicalTrials.gov · Last updated 12 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 2 Jul 2018
- Start date
- 14 Sept 2018
- Primary completion date
- Dec 2026
- Lead sponsor
- Oregon Health and Science University
- Diseases
- Alzheimer disease
- NCT number
- NCT03761381
What you commit to
- Study type: Observational
- Planned participants: 20
- From 14 Sept 2018 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber intraocular lens implantation
Other illness
- 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.)
- Uncontrolled hypertension. : SBP \> 170 or DBP \> 100
- Arrhythmia: irregular pulse, or heart rate not between 50 and 110 beats per minute
Lab values
- Diabetes for more than 10 years or hemoglobin A1C level of \> 10 within the 180 days prior to OCT scanning.
Other
- Media opacity such as cataract, corneal scar, or vitreous opacity that could interfere with retinal imaging.
- 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.
- Pregnancy or breast feeding.
Who the study is looking for
- 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.
Age in the registry: 55 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.