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OCTA in Mild Cognitive Impairment and Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03233646
Recruitment Status : Active, not recruiting
First Posted : July 28, 2017
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
This study aims 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 mild cognitive impairment (MCI) and Alzheimer's Disease (AD)

Condition or disease Intervention/treatment Phase
Alzheimer Disease Mild Cognitive Impairment Retinal Vascular Device: Retinal Imaging Not Applicable

Detailed Description:

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.


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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Case
100 patients with MCI and/or AD
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.
Device: Retinal Imaging
Non-invasive OCTA scan of retina




Primary Outcome Measures :
  1. Foveal avascular zone [ Time Frame: 12 months ]
    Differences in Foveal avascular zone size

  2. Vessel Density [ Time Frame: 12 months ]
    Differences in Superficial and Deep Capillary Plexus Vessel Density

  3. Choroidal Thickness [ Time Frame: 12 months ]
    Differences in subfoveal choroidal thickness between the two groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Dilraj Grewal, MD Duke University
Study Director: Sharon Fekrat, MD Duke University

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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

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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:
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