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Clinical Trial Summary

This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.


Clinical Trial Description

Using a multidisciplinary approach, this study aims to yield new insight into the vascular and structural pathophysiology of neurodegenerative disease. The investigators propose to develop and evaluate imaging biomarkers from OCT, OCTA, and UWF fundus photos to assess the structure and function of the retinal and choroidal microvasculature and structure in these individuals. The investigators hypothesize that microvascular and structural network alterations in the retina and choroid may mirror and possibly precede changes in the cerebral microcirculation seen in these neurodegenerative diseases. Using advanced image analysis and machine learning techniques, the investigators aim to evaluate markers of reduced capillary blood flow and non-perfusion in the superficial retinal vascular plexus and choriocapillaris imaged using OCT and OCTA, in a resolution not previously possible, that would complement already established retinal structural markers and increase their sensitivity and specificity in the earlier detection of these neurodegenerative diseases. This study looks to provide a proof of concept for retinal and choroidal imaging-based microvascular and structural biomarkers as an effective screening tool for neurodegenerative disease, particularly during in cognitive aging. The protocol for this study was amended and the record was updated accordingly. ;


Study Design


Related Conditions & MeSH terms

  • Alzheimer Disease
  • Alzheimer's Disease
  • Amyotrophic Lateral Sclerosis
  • Amyotrophic Lateral Sclerosis (ALS)
  • Aphasia, Primary Progressive
  • Brain Injuries
  • Brain Injuries, Traumatic
  • Cognitive Dysfunction
  • Concussion
  • Dementia
  • Down Syndrome
  • Frontotemporal Dementia
  • Huntington Disease
  • Lewy Body Dementia
  • Lewy Body Disease
  • Mild Cognitive Impairment
  • Motor Neuron Disease
  • Multiple Sclerosis
  • Neuro-Degenerative Disease
  • Neurodegenerative Diseases
  • Normal Cognition
  • Parkinson Disease
  • Parkinson's Disease
  • Pick Disease of the Brain
  • Post-Traumatic Stress Disorder
  • Sclerosis
  • Stress Disorders, Post-Traumatic
  • Stress Disorders, Traumatic
  • Traumatic Brain Injury

NCT number NCT03233646
Study type Observational
Source Duke University
Contact Sharon Fekrat, MD FACS FASRS
Phone 919-681-3937
Email imind@duke.edu
Status Recruiting
Phase
Start date July 20, 2017
Completion date December 31, 2025

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