An observational study in Alzheimer's Disease, Mild Cognitive Impairment and Parkinson's Disease, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Duke University · Observational
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.
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Neurology Clinics and the community.
Exclusion Criteria:
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.
Patients with (MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)
Device: Retinal and Choroidal Imaging
Controls will be recruited from the relatives/attendants of study participants or will be patients themselves and will not have a neurodegenerative disease diagnosis.
Device: Retinal and Choroidal Imaging
Non-invasive OCT, OCTA, and UWF fundus photography of retina
Change in ganglion cell-inner plexiform layer (GCIPL) thickness
Ganglion cell inner plexiform layer thickness as measured on optical coherence tomography scan of macula
Time frame: Baseline, 1 year
Change in retinal nerve fiber layer (RNFL) thickness
Retinal nerve fiber layer thickness as measured on optical coherence tomography scan of macula
Time frame: Baseline, 1 year
Change in central subfield thickness (CST)
Central subfield thickness as measured on optical coherence tomography scan of macula
Time frame: Baseline, 1 year
Change in choroidal vascularity index (CVI)
Choroidal vascularity index as measured using the COIN software in 1500 um area centered on the fovea
Time frame: Baseline, 1 year
Change in foveal avascular zone (FAZ) area
Foveal avascular zone area as measured in the superficial capillary plexus on 3mm optical coherence tomography angiography scan of the macula
Time frame: Baseline, 1 year
Change in average perfusion density (PD)
Average perfusion density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula
Time frame: Baseline, 1 year
Change in average vessel density (VD)
Average vessel density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula
Time frame: Baseline, 1 year
Change in average capillary perfusion density (CPD)
Capillary perfusion density as measured on peripapillary 4.5mm optical coherence tomography angiography scan
Time frame: Baseline, 1 year
Change in average capillary flux index (CFI)
Capillary flux index as measured on peripapillary 4.5mm optical coherence tomography angiography scan
Time frame: Baseline, 1 year
Change in retinal vessel tortuosity
Retinal vessel tortuosity measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software
Time frame: Baseline, 1 year
Change in retinal vessel width gradient
Retinal vessel width gradient measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software
Time frame: Baseline, 1 year
Change in retinal vessel fractal dimension
Retinal vessel fractal dimension measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software
Time frame: Baseline, 1 year
Plan to share: No
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