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Clinical Trials/NCT01996215
NCT01996215
Completed
N/A

Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration

Duke University1 site in 1 country238 target enrollmentApril 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Age-Related Macular Degeneration
Sponsor
Duke University
Enrollment
238
Locations
1
Primary Endpoint
Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
June 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Vision loss attributable to AMD
  • Age match (± 5 yrs)
  • Gender match
  • Education match (± 4yrs)
  • Normal macular exam

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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