Brain Connectivity in Age-Related Macular Degeneration

Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01996215

Enrollment

238

Registered

2013-11-27

Start date

2014-04-30

Completion date

2018-06-30

Last updated

2019-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results