Using retinal imaging to study blood flow and amyloid deposits in dementia
Using Optical Coherence Tomography and Noninvasive Retinal Amyloid Imaging to Capture Retinal Changes Associated With Dementia
This study is testing if special eye scans can help us see changes in blood flow and amyloid deposits in the eyes of people with dementia compared to those without it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT03761381 on ClinicalTrials.gov |
What this trial studies
This observational study aims to utilize optical coherence tomography (OCT) angiography to assess changes in retinal blood vessels and blood flow in individuals diagnosed with dementia. Additionally, it seeks to identify amyloid protein deposits in the retinas of these participants. The study will include both individuals with dementia and dementia-free controls to compare findings. Participants will undergo noninvasive retinal imaging procedures to gather data on these conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals aged over 55 with a physician-confirmed diagnosis of probable Alzheimer's disease or mild dementia.
Not a fit: Patients with severe dementia or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection and monitoring of dementia-related changes, potentially leading to improved patient management.
How similar studies have performed: While the use of OCT in dementia research is emerging, this specific approach combining OCT angiography and retinal amyloid imaging is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: David Huang, MD, PhD — Oregon Health and Science University
- Study coordinator: Denzil Romfh, OD
- Email: romfhd@ohsu.edu
- Phone: 503-494-4351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.