Brain Connectivity in Age-Related Macular Degeneration

NCT ID: NCT01996215

Last Updated: 2019-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

238 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2018-06-30

Brief Summary

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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

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Conditions

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Age-Related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AMD controls

No interventions assigned to this group

AMD cases

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather Whitson, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Medicine

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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R01AG043438

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00046073

Identifier Type: -

Identifier Source: org_study_id

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