Retinal Imaging in Neurodegenerative Disease

Duke University

Status: Enrolling

Conditions: Normal Cognition; Down Syndrome; Lewy Body Dementia; APOE-4 Positive; Parkinson's Disease; Amyotrophic Lateral Sclerosis (ALS); Neuro-Degenerative Disease; Traumatic Brain Injury; Alzheimer's Disease; Post-Traumatic Stress Disorder; Frontotemporal Dementia; Concussion; Multiple Sclerosis; Mild Cognitive Impairment; Huntington Disease

Treatments: Device: Retinal and Choroidal Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT03233646

Pro00111831

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,000 participants in 2 patient groups

Case

Description:

Patients with (MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)

Treatment:

Device: Retinal and Choroidal Imaging

Controls

Description:

Controls will be recruited from the relatives/attendants of study participants or will be patients themselves and will not have a neurodegenerative disease diagnosis.

Treatment:

Device: Retinal and Choroidal Imaging