Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2017-07-20
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case
Patients with (MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)
Retinal and Choroidal Imaging
Non-invasive OCT, OCTA, and UWF fundus photography of retina
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.
Retinal and Choroidal Imaging
Non-invasive OCT, OCTA, and UWF fundus photography of retina
Interventions
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Retinal and Choroidal Imaging
Non-invasive OCT, OCTA, and UWF fundus photography of retina
Eligibility Criteria
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Inclusion Criteria
* Adults without neurodegenerative disease
Exclusion Criteria
* Eyes that have had intraocular surgery, other than cataract surgery.
18 Years
ALL
Yes
Sponsors
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University of Edinburgh in Scotland
UNKNOWN
Tan Tock Seng Hospital in Singapore
UNKNOWN
Queens University of Belfast United Kingdom
UNKNOWN
Duke University
OTHER
Responsible Party
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Principal Investigators
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Sharon Fekrat, MD FACS FASRS
Role: PRINCIPAL_INVESTIGATOR
Duke University
Dilraj Grewal, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Zhao W, Robbins CB, Grewal DS, Patel H, Soundararajan S, Liu AJ, Johnson KG, Agrawal R, Petrella JR, Stinnett SS, Parker D, Fekrat S. Correlating retinal and choroidal vascular parameters with volumetric MRI in Alzheimer's disease and amnestic mild cognitive impairment. BMC Ophthalmol. 2025 Jul 1;25(1):365. doi: 10.1186/s12886-025-04157-x.
Robbins CB, Akrobetu D, Ma JP, Stinnett SS, Soundararajan S, Liu AJ, Johnson KG, Grewal DS, Fekrat S. ASSESSMENT OF RETINAL MICROVASCULAR ALTERATIONS IN INDIVIDUALS WITH AMNESTIC AND NONAMNESTIC MILD COGNITIVE IMPAIRMENT USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2022 Jul 1;42(7):1338-1346. doi: 10.1097/IAE.0000000000003458.
Other Identifiers
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Pro00111831
Identifier Type: -
Identifier Source: org_study_id
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