NCT03761381 · Oregon Health and Science University
OCT Angiography and NRAI in Dementia
What this study is 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Portland, Oregon
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 12, 2025 · Source of record for eligibility and locations