OCTA in Mild Cognitive Impairment and Alzheimer's Disease
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| ClinicalTrials.gov Identifier: NCT03233646 |
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Recruitment Status :
Active, not recruiting
First Posted : July 28, 2017
Last Update Posted : April 8, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer Disease Mild Cognitive Impairment Retinal Vascular | 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). 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.
The investigators hypothesize that microvascular network alterations in the retina mirror and possibly precede changes in the cerebral microcirculation seen in MCI and AD. 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.
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 : | 450 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 : | April 1, 2021 |
| Estimated Study Completion Date : | April 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Case
100 patients with MCI and/or AD
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Device: Retinal Imaging
Non-invasive OCTA scan of retina |
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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.
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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 and AD)
- 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
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| Principal Investigator: | Dilraj Grewal, MD | Duke University | |
| Study Director: | Sharon Fekrat, MD | Duke University |
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT03233646 History of Changes |
| Other Study ID Numbers: |
Pro00082598 |
| First Posted: | July 28, 2017 Key Record Dates |
| Last Update Posted: | April 8, 2019 |
| Last Verified: | April 2019 |
| 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 | |
| Device Product Not Approved or Cleared by U.S. FDA: | No | |
| Pediatric Postmarket Surveillance of a Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Keywords provided by Duke University:
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OCT angiography Optical Coherence Tomography Vessel Density |
Superficial Capillary Plexus retinal microvasculature OCTA |
Additional relevant MeSH terms:
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Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |