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| Name | Class |
|---|---|
| University of Edinburgh in Scotland | UNKNOWN |
| Tan Tock Seng Hospital in Singapore | UNKNOWN |
| Queens University of Belfast United Kingdom | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retinal and Choroidal Imaging | Device | Non-invasive OCT, OCTA, and UWF fundus photography of retina |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in ganglion cell-inner plexiform layer (GCIPL) thickness | Ganglion cell inner plexiform layer thickness as measured on optical coherence tomography scan of macula | 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 | Baseline, 1 year |
| Change in central subfield thickness (CST) | Central subfield thickness as measured on optical coherence tomography scan of macula | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in retinal vessel tortuosity | Retinal vessel tortuosity measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software | Baseline, 1 year |
| Change in retinal vessel width gradient |
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Inclusion Criteria:
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.
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Neurology Clinics and the community.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharon Fekrat, MD FACS FASRS | Contact | 919-681-3937 | imind@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sharon Fekrat, MD FACS FASRS | Duke University | Principal Investigator |
| Dilraj Grewal, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40598011 | Derived | 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. | |
| 35723922 |
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| Baseline, 1 year |
| Change in average capillary perfusion density (CPD) | Capillary perfusion density as measured on peripapillary 4.5mm optical coherence tomography angiography scan | Baseline, 1 year |
| Change in average capillary flux index (CFI) | Capillary flux index as measured on peripapillary 4.5mm optical coherence tomography angiography scan | Baseline, 1 year |
Retinal vessel width gradient measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software
| Baseline, 1 year |
| Change in retinal vessel fractal dimension | Retinal vessel fractal dimension measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software | Baseline, 1 year |
| 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. |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D010300 | Parkinson Disease |
| D009103 | Multiple Sclerosis |
| D006816 | Huntington Disease |
| D020961 | Lewy Body Disease |
| D057180 | Frontotemporal Dementia |
| D000690 | Amyotrophic Lateral Sclerosis |
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| D013313 | Stress Disorders, Post-Traumatic |
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D057174 | Frontotemporal Lobar Degeneration |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013118 | Spinal Cord Diseases |
| D016472 | Motor Neuron Disease |
| D009468 | Neuromuscular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D025063 | Chromosome Disorders |
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