Brain Connectivity in Age-Related Macular Degeneration

Overview

This study is to determine how cognitive deficits (e.g.,verbal fluency deficit) in patients with Age-Related Macular Degeneration (AMD) relate to specific aspects of brain and function. The study team will assess whether the "brain signatures" associated with specific cognitive deficits differ in older adults with and without AMD.

Full Title of Study: “Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2018

Arms, Groups and Cohorts

  • AMD controls
  • AMD cases

Clinical Trial Outcome Measures

Primary Measures

  • Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration
    • Time Frame: Baseline, anticipated 2 years
    • All Participants will receive neurocognitive testing, health and lifestyle surveys, audiometry and eye exams. Brain MRIs will be obtained on half the cohort, as this will provide sufficient power to accomplish the Aims that involve neuroimaging data. These MRIs will be obtained while participants are in the “resting state” meaning they are awake but not instructed to perform specific scanner. Two years after baseline exams, participants will return for repeat data collection. Participants who received an MRI at baseline will receive repeat resting-state, brain MRI at 2-year follow-up, unless they have developed contradictions to MRI scans in the interim.

Participating in This Clinical Trial

Inclusion Criteria

AMD

  • Vision loss attributable to AMD

Controls

  • Age match (± 5 yrs)
  • Gender match
  • Education match (± 4yrs)
  • Normal macular exam

Exclusion Criteria

AMD

  • Other significant eye pathology
  • Mod/severe dementia
  • Communication barrier that precludes testing

Controls

  • Other significant eye pathology
  • Mod/severe dementia
  • Communication barrier that precludes testing

MRI subset

  • Devices or material incompatible with 3.0 Tesla MRI
  • Conditions that may interfere with interpretation of fMRI (e.g. history of stroke, brain tumor or previous brain surgery; psychoactive medications; seizure disorder)
  • Claustrophobia
  • Left-handed
  • Body weight > 300 lbs
  • Pregnant women

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Duke University
  • Collaborator
    • National Institute on Aging (NIA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Heather Whitson, MD, Principal Investigator, Duke Medicine

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