Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Vision loss attributable to AMD
- •Age match (± 5 yrs)
- •Gender match
- •Education match (± 4yrs)
- •Normal macular exam
排除标准
- •Other significant eye pathology
- •Mod/severe dementia
- •Communication barrier that precludes testing
- •Other significant eye pathology
- •Mod/severe dementia
- •Communication barrier that precludes testing
- •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
结局指标
主要结局
Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration
时间窗: 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.
次要结局
未报告次要终点