OCT Angiography and NRAI in Dementia

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Nov 29, 2018

Keywords

ClinConnect Summary

This clinical trial, titled "OCT Angiography and NRAI in Dementia," is looking to understand how changes in the blood vessels in the eyes might relate to conditions like Alzheimer’s disease and other forms of dementia. Researchers will use a special imaging technique called optical coherence tomography (OCT) to map the blood vessels and check for harmful protein deposits in the retinas of participants. The goal is to see if these eye changes can help in diagnosing or understanding dementia better.

To be eligible for this study, participants must be over 55 years old and have a confirmed diagnosis of mild Alzheimer’s disease or dementia, or they can be healthy individuals without dementia for comparison. Participants should also have a certain level of vision and be able to follow study procedures. Those who join can expect a thorough eye examination, and they will need a caregiver or legal representative to help with the consent process. It’s important to note that individuals with certain eye conditions, neurological diseases, or other specific health issues may not be able to participate. This study aims to improve our understanding of dementia through eye health and could lead to better detection methods in the future.

Gender

ALL

Eligibility criteria

• 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.