NCT03761381RecruitingAccepts Healthy Volunteers
OCT Angiography and NRAI in Dementia
Oregon Health and Science University
Start Date
9/14/2018
Completion Date
12/1/2027
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.
Eligibility Criteria
Age Range: 55 years to No maximum
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.
Interventions
DEVICE
Optical Coherence Tomography Angiography (OCTA) Imaging
DEVICE
Noninvasive Retinal Amyloid Imaging (NRAI)
Conditions
Alzheimer DiseaseDementiaMild Cognitive Impairment
Locations
Oregon Health & Science University
Portland, Oregon 97239
United States