Overview

This trial is active, not recruiting.

Condition age-related macular degeneration
Sponsor Duke University
Collaborator National Institute on Aging (NIA)
Start date April 2014
End date December 2018
Trial size 300 participants
Trial identifier NCT01996215, Pro00046073, R01AG043438

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration
time frame: Baseline, anticipated 2 years

Eligibility Criteria

Male or female participants from 50 years up to 90 years old.

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

Additional Information

Official title Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration
Principal investigator Heather Whitson, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Duke University.