Brain Connectivity in Age-Related Macular Degeneration

Age-Related Macular Degeneration Clinical Trial

Official title:

Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01996215
• Other study ID #: Pro00046073
• Secondary ID: R01AG043438
• Status: Completed
• Start date: April 2014
• Est. completion date: June 2018

Study information

• Verified date: December 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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