ACTRN12616001679471已完成未知
A Cross-Sectional study to explore the correlation between PET SUVR and amyloid-beta plaques in the retina, identified by fluorescence imaging using the EidonTM (RetiaTM) retinal imaging system with and without curcumin labeling.
euroVision Imaging LLC0 个研究点目标入组 286 人开始时间: 2016年12月6日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 286
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
入排标准
- 年龄范围
- 60 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Enrolled in the AIBL study with a A Ddiagnosis of MCI, or healthy controls within 36 months as per the AIBL criteria at the screening visit .
- •2. PET amyloid brain scan within 36 months of baseline visit
- •3.Participant must be able to provide written informed consent in English.
- •4. Male or Female age 60 years or older at the screening visit
- •5. In the opinion of the retinal photographer, clear ocular media and pupillary dilation to allow for ocular imaging
排除标准
- •1.The participant has advanced retinal disease, advanced cataracts or other advanced ocular conditions that in the opinion of the investigator are likely to affect obtaining clear images of the retina.
- •2. Participant has had prior ocular surgery within 2 months of planned retinal imaging, or is still taking post-operative ocular medications at first day of retinal imaging.
- •3. Participants with known current gallstone.
- •4. Participants who have undergone angioplasty in the last 3 months.
- •5Participants who have had major surgery within 4 weeks of trial inclusion or planned surgical procedure during the trial period.
- •6. Significant haemorrhagic event (in past 12 months) or cardiovascular disease ( ie, history of myocardial infarction within past 6 months of trial inclusion, congestive cardiac failure NYHA grade II ).
- •7.Participant with retinitis pigmentosa.
- •8. Participants with current bile duct obstruction (participants who have undergone a cholecystectomy will be considered eligible).
- •9. Participants with significant uncontrolled gastrointestinal disorders (including stomach ulcers and uncontrolled hyperacidity disorders) which in the opinion of the investigator will be aggravated by the intake of curcumin.
- •10. Participants with known allergy to Tropicamide eye drops, Vitamin E or turmeric.
- •11.Participation in another clinical trial within 30 days prior to visit one (with the exception of the AIBL trial).
- •12. In the opinion of the investigator, the participant’s cognitive function is no longer consistent with the AIBL diagnosis.
研究者
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