Status:
RECRUITING
OCT Angiography and NRAI in Dementia
Lead Sponsor:
Oregon Health and Science University
Conditions:
Alzheimer Disease
Dementia
Eligibility:
All Genders
55+ years
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 dementi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 14 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03761381
Start Date
September 14 2018
End Date
December 1 2027
Last Update
September 12 2025
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239