Brain Connectivity in Age-Related Macular Degeneration

Completed

• Conditions: Age-Related Macular Degeneration

• Registration Number: NCT01996215
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-27
• Study Start: 2014-04
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-12
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

AMD

• Vision loss attributable to AMD

Controls

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States