NCT07254234尚未招募不适用
Exploratory Study to Assess Utility of RetiSpec Artificial Intelligence Powered Retinal Imaging Solution in Detecting Amyloid Pathology in United Arab Emirates Nationals With Mild Impairment of Cognition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage of Participants with the Same Results on the Blood Test and Retinal Scan
研究概览
简要总结
The purpose of this study is to test the use of a screening tool to detect changes in the eye that are associated with Alzheimer's disease in adult participants with memory issues. For each participant, the study will last up to one month and requires one visit to the research site.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are overtly healthy as determined by medical evaluation, including medical history and physical examination.
- •Have mild memory complaints or a diagnosis of mild cognitive impairment.
- •Have undergone genotyping for apolipoprotein E (APOE) and are willing to make results available to the investigator.
- •Montreal Cognitive Assessment (MoCA) score of greater than or equal to 22 and less than or equal to 28.
排除标准
- •Have any medical condition that, in the opinion of the investigator, would be a contraindication to participation in the study.
- •Have an existing diagnosis of AD or other dementia.
- •Have contradictions to or an allergy to the ophthalmic dilating agents.
- •Have known diagnosis of severe glaucoma or severe cataracts; have a significant refractive error (more than 12 diopters [D] of spherical equivalent refraction); or have any ocular media opacity that prevents imaging of the retina (that is, severe cataract). Note: mild to moderate cataracts or vision correction with glasses or contact lenses are not exclusion criteria.
- •Current or previous treatment with anti-amyloid medications.
- •Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
结局指标
主要结局
Percentage of Participants with the Same Results on the Blood Test and Retinal Scan
时间窗: Day 1
次要结局
- Percentage of Participants who Report High or Moderate Satisfaction with Retinal Scan(Day 1)
研究者
研究点 (1)
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