Skip to main content
OpenTrials
Completed

NCT Number: NCT01996215

Brain Connectivity in Age-Related Macular Degeneration

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 27, 2013
Registry last updated
Feb 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.