OCTA in Mild Cognitive Impairment and Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT03233646 |
Recruitment Status :
Recruiting
First Posted : July 28, 2017
Last Update Posted : September 2, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease Mild Cognitive Impairment Retinal Vascular Parkinson Disease Multiple Sclerosis Huntington Disease Neuro-Degenerative Disease | Device: Retinal Imaging | Not Applicable |
Using a multidisciplinary approach, this study aims to yield new insight into the vascular pathophysiology of mild cognitive impairment (MCI) and Alzheimer's Disease (AD) Parkinson's Disease (PD) or other neurodegenerative disease. The investigators propose to develop and evaluate biomarkers using non-invasive optical coherence tomography angiography (OCTA) to assess the structure and function of the retinal microvasculature in persons with MCI and AD, PD or other neurodegenerative disease multiple sclerosis, and Huntington's disease..
The investigators hypothesize that microvascular network alterations in the retina mirror and possibly precede changes in the cerebral microcirculation seen in these diseases. Using advanced image analysis, the investigators aim to evaluate markers of reduced capillary blood flow and non-perfusion in the superficial and deep retinal vascular plexuses and choriocapillaris imaged using OCTA, in a resolution not previously possible, that would complement already established retinal structural markers and increase their sensitivity and specificity in the early detection of MCI and AD, PD, multiple sclerosis, and Huntington's disease. or other neurodegenerative disease.
This study looks to provide a proof of concept for OCTA-based retinal microvascular biomarkers as an effective screening tool in cognitive aging.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Evaluating the Retinal Microvasculature in Mild Cognitive Impairment and Alzheimer's Disease Using Optical Coherence Tomography Angiography |
Actual Study Start Date : | July 20, 2017 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
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Experimental: Case
500 patients with MCI and/or AD, PD, multiple sclerosis, and Huntington's disease.or other neuro-degenerative disease
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Device: Retinal Imaging
Non-invasive OCTA scan of retina |
Active Comparator: Controls
Controls will be recruited from the relatives/attendants of the patients , or will be patients themselves, and will not have a diagnosis of MCI/AD/PD/MS/Huntington's Disease or other neuro-degenerative disease.
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Device: Retinal Imaging
Non-invasive OCTA scan of retina |
- Foveal avascular zone [ Time Frame: 12 months ]Differences in Foveal avascular zone size
- Vessel Density [ Time Frame: 12 months ]Differences in Superficial and Deep Capillary Plexus Vessel Density
- Choroidal Thickness [ Time Frame: 12 months ]Differences in subfoveal choroidal thickness between the two groups

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients with neurodegenerative disease (MCI/ADPD/MS/HD)
- Age-gender-race-matched controls.
Exclusion Criteria:
- History of known or suspected diagnosis of non-AD
- Associated dementia
- Diabetes mellitus
- Inability to cooperate with or complete testing
- Evidence of glaucoma
- Macular degeneration
- Other neurologic or age-related ocular conditions that would impact OCTA segmentation. -Eyes that have had intraocular surgery, other than cataract surgery, will be excluded
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233646
Contact: Dilraj Grewal, MD | 919-684-4458 | dilraj.grewal@duke.edu |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27705 | |
Contact: Dilraj Grewal, MD 919-684-4458 dilraj.grewal@duke.edu | |
Sub-Investigator: Sharon Fekrat, MD | |
Sub-Investigator: James Burke, MD |
Principal Investigator: | Dilraj Grewal, MD | Duke University | |
Study Director: | Sharon Fekrat, MD | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT03233646 |
Other Study ID Numbers: |
Pro00082598 |
First Posted: | July 28, 2017 Key Record Dates |
Last Update Posted: | September 2, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
OCT angiography Optical Coherence Tomography Vessel Density |
Superficial Capillary Plexus retinal microvasculature OCTA |
Parkinson Disease Multiple Sclerosis Alzheimer Disease Huntington Disease Neurodegenerative Diseases Cognitive Dysfunction Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Demyelinating Autoimmune Diseases, CNS |
Autoimmune Diseases of the Nervous System Demyelinating Diseases Autoimmune Diseases Immune System Diseases Dementia Tauopathies Neurocognitive Disorders Mental Disorders Cognition Disorders Chorea Dyskinesias Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn |