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NCT03233646 | RECRUITING | Alzheimer's Disease


Retinal Imaging in Neurodegenerative Disease
Sponsor:

Duke University

Brief Summary:

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.

Condition or disease

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

Intervention/treatment

Retinal and Choroidal Imaging

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 2000 participants
Official Title : Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study
Actual Study Start Date : 2017-07-20
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.

Retinal Imaging in Neurodegenerative Disease

Location Details

NCT03233646


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Locations


RECRUITING

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27705

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