OCT Angiography and NRAI in Dementia
Using Optical Coherence Tomography and Noninvasive Retinal Amyloid Imaging to Capture Retinal Changes Associated With Dementia
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2018
CompletedStudy Start
First participant enrolled
September 14, 2018
CompletedFirst Posted
Study publicly available on registry
December 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
September 12, 2025
September 1, 2025
8.2 years
July 2, 2018
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retinal amyloid protein detection
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.
1 day
Secondary Outcomes (2)
Decreased blood flow
1 day
Decreased retinal perfusion
1 day
Study Arms (2)
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 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.
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.
Eligibility Criteria
Dementia subjects will be recruited from the Layton Aging \& Alzheimer's Disease Clinic at Oregon Health \& Science University. Dementia-free subjects will be recruited from those currently being followed in the Layton Aging \& Alzheimer's Disease Center longitudinal aging study with MRI and amyloid PET imaging.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Huang, MD, PhD
Oregon Health and Science University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- David Huang, MD, PhD, Peterson Professor of Ophthalmology and Professor orf Biomedical Engineering
Study Record Dates
First Submitted
July 2, 2018
First Posted
December 3, 2018
Study Start
September 14, 2018
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
September 12, 2025
Record last verified: 2025-09