OCTA in Mild Cognitive Impairment and Alzheimer's Disease

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03233646
Collaborator
University of Edinburgh (Other)
1,000
1
2
65.4
15.3

Study Details

Study Description

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.

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

Study Type:
Interventional
Anticipated 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 :
Jul 20, 2017
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Foveal avascular zone [12 months]

    Differences in Foveal avascular zone size

  2. Vessel Density [12 months]

    Differences in Superficial and Deep Capillary Plexus Vessel Density

  3. Choroidal Thickness [12 months]

    Differences in subfoveal choroidal thickness between the two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27705

Sponsors and Collaborators

  • Duke University
  • University of Edinburgh

Investigators

  • Principal Investigator: Dilraj Grewal, MD, Duke University
  • Study Director: Sharon Fekrat, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03233646
Other Study ID Numbers:
  • Pro00082598
First Posted:
Jul 28, 2017
Last Update Posted:
Sep 27, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
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
Keywords provided by Duke University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 27, 2021