NCT01937221已完成不适用
Novel Retinal Imaging Biomarkers in Early Alzheimer's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Nerve fiber layer/ganglion cell layer (NFL/GCL) abnormality score
研究概览
简要总结
The goal of this study is to create new retinal imaging processing software useful for the development of novel retinal biomarkers of cognitive impairment associated with Alzheimer's disease (AD).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Result of the standard neuropsychological assessment
- •Are men or postmenopausal women, at least 55 years of age. Postmenopausal women are defined as women who have had a hysterectomy and/or bilateral oophorectomy; or who have been amenorrheic for at least 2 years;
- •Fluency in English
- •Participants in mild cognitive impairment (MCI)/prodromal and mild-to-moderate dementia groups must assign a surrogate for purposes of informed consent and help with protocol compliance.
排除标准
- •Known or suspected diagnosis of non-AD, associated dementia;
- •Major ophthalmologic comorbidities: Ruptured globe, retinal vascular occlusive disease, retinal artery occlusion, anterior ischemic optic neuropathy, media opacification due to corneal abnormalities or cataract that prevent ocular and OCT examination, glaucoma, wet (neovascular) age-related macular degeneration, history of intravitreal injections, and macular edema. If two eyes satisfy the inclusion criteria, both eyes will be included in the study.
结局指标
主要结局
Nerve fiber layer/ganglion cell layer (NFL/GCL) abnormality score
时间窗: Baseline
The study will determine the significance of difference in NFL/GCL score between the AD subject groups at baseline.
NFL/GCL abnormality score
时间窗: 12 months
The study will determine the significance of difference in NFL/GCL score between the AD subject groups at baseline. Dependent on baseline results, some subjects may have the opportunity to have another measurement taken at 12 months.
次要结局
- Drusen/plaque score(12 months)
- Total drusen area(12 months)
研究者
研究点 (1)
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