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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
Sponsor:
Collaborators:
Alzheimer's Drug Discovery Foundation
University of Edinburgh
Information provided by (Responsible Party):
Duke University

Study Description
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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), Parkinson's Disease (PD) or other neurodegenerative disease, multiple sclerosis, and Huntington's disease.

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

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) 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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Case
500 patients with MCI and/or AD, PD, multiple sclerosis, and Huntington's disease.or other neuro-degenerative disease
 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.
 Device: Retinal Imaging
Non-invasive OCTA scan of retina


Outcome Measures
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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


Eligibility Criteria
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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/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.
Contacts and Locations
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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


Contacts
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Contact: Dilraj Grewal, MD 919-684-4458 dilraj.grewal@duke.edu

Locations
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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         
Sponsors and Collaborators
Duke University
Alzheimer's Drug Discovery Foundation
University of Edinburgh
Investigators
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Principal Investigator: Dilraj Grewal, MD Duke University
Study Director: Sharon Fekrat, MD Duke University
More Information
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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

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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
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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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