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临床试验/NCT04567745
NCT04567745已完成1 期

Clinical Validation of an Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Indicating Cognitive Decline

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年9月29日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
Mayo Clinic
入组人数
80
试验地点
1
主要终点
retinopathy features identification

研究概览

简要总结

This study aims to provide clinical validation of EyeQuant, a fully automated retinal image analysis system for computation of vascular biomarkers indicative of cognitive disorders, using retinal fundus photographs collected from patients with mild cognitive impairment, Alzheimer's disease, and vascular dementia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients older than 18 years and diagnosed with mild cognitive impairment (MCI), Alzheimer's disease (AD), or vascular cognitive impairment and/or dementia (VaD).

排除标准

  • •Children and subjects with other diagnoses than those mentioned in the inclusion criteria.
  • •Patients without the means to visit the clinic on the assigned dates.
  • •Patients who are pregnant or are expecting to become pregnant.

研究组 & 干预措施

Cognitive diagnosis

Other

干预措施: Retinal fundus photography (Diagnostic Test)

结局指标

主要结局

retinopathy features identification

时间窗: 12 months

The retinal vascular parameters computed using EyeQuant will be compared against the current gold-standard, based on expert annotations

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oana M. Dumitrascu

Principal Investigator

Mayo Clinic

研究点 (1)

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