OCT Angiography and NRAI in Dementia
Recruiting · NCT03761381 · Observational (researchers observe without assigning treatment) · Lead sponsor: Oregon Health and Science University
View the official record on ClinicalTrials.gov →Interventions studied
Noninvasive Retinal Amyloid Imaging (NRAI)Optical Coherence Tomography Angiography (OCTA) Imaging
What this trial 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.
Who can take part
Age range
55 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
1 location listed across 1 US state.
- Oregon Health & Science University - Portland, Oregon, United States