Retinal Imaging in Neurodegenerative Disease
Purpose
This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.
Conditions
- Alzheimer's Disease
- Mild Cognitive Impairment
- Parkinson's Disease
- Multiple Sclerosis
- Huntington Disease
- Lewy Body Dementia
- Frontotemporal Dementia
- Amyotrophic Lateral Sclerosis (ALS)
- APOE-4 Positive
- Traumatic Brain Injury
- Concussion
- Post-Traumatic Stress Disorder
- Down Syndrome
- Neuro-Degenerative Disease
- Normal Cognition
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Adults with neurodegenerative disease ((MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome) - Adults without neurodegenerative disease
Exclusion Criteria
- Inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition. - Eyes that have had intraocular surgery, other than cataract surgery. If two eyes satisfy the inclusion criteria, both eyes will be included in the study. If one eye satisfies the inclusion criteria, the eye that qualifies will be included in the study.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Case | Patients with (MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome) |
|
| Controls | Controls will be recruited from the relatives/attendants of study participants or will be patients themselves and will not have a neurodegenerative disease diagnosis. |
|
Recruiting Locations
Durham 4464368, North Carolina 4482348 27705
More Details
- NCT ID
- NCT03233646
- Status
- Recruiting
- Sponsor
- Duke University
Detailed Description
Using a multidisciplinary approach, this study aims to yield new insight into the vascular and structural pathophysiology of neurodegenerative disease. The investigators propose to develop and evaluate imaging biomarkers from OCT, OCTA, and UWF fundus photos to assess the structure and function of the retinal and choroidal microvasculature and structure in these individuals. The investigators hypothesize that microvascular and structural network alterations in the retina and choroid may mirror and possibly precede changes in the cerebral microcirculation seen in these neurodegenerative diseases. Using advanced image analysis and machine learning techniques, the investigators aim to evaluate markers of reduced capillary blood flow and non-perfusion in the superficial retinal vascular plexus and choriocapillaris imaged using OCT and OCTA, in a resolution not previously possible, that would complement already established retinal structural markers and increase their sensitivity and specificity in the earlier detection of these neurodegenerative diseases. This study looks to provide a proof of concept for retinal and choroidal imaging-based microvascular and structural biomarkers as an effective screening tool for neurodegenerative disease, particularly during in cognitive aging. The protocol for this study was amended and the record was updated accordingly.