Brain Connectivity in Age-Related Macular Degeneration

NCT01996215 | Completed

• 2 other identifiers: Pro00046073R01AG043438
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration

  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.

  Baseline, anticipated 2 years

Study Arms (2)

AMD controls

AMD cases

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include 300 participants: 150 subjects with AMD plus 150 age, gender, and education-matched adults without AMD. All participants will receive baseline and 2 year neurocognitive tests and a subset will provide structural and "resting stage"functional magnetic resonance images (MRIs) at each time point.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Heather Whitson, MD

  Duke Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 27, 2013
• Study Start: April 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 7, 2019

Record last verified: 2018-12

Locations

US (1)