ACTRN12615000677505已完成2 期
A study to evaluate retinal amyloid plaques in a middle-aged control cohort, utilizing a retinal imaging system and curcumin labeling
McCusker Alzheimer's Disease Foundation0 个研究点目标入组 40 人开始时间: 2015年6月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1. Participant must be cognitive normal (as assessed in the AIBL study).
- •2. Participant must be able to provide written informed consent in English.
- •3. Male or Female age 40-60 years.
- •4.Participants must have had a brain amyloid imaging (PET scan) or plan to undertake a PET scan as part of the AIBL study within 6 months of completing the NVI003.B study.
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 gallstones.
- •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. Women who are of child bearing potential who do not agree to use reliable contraception from day 0 until at least 6 weeks after the last study drug administration. Pregnant or lactating females are not eligible. Women of childbearing potential must have a negative pregnancy test done prior to commencing study drug.
- •12.Participation in another clinical trial within 30 days prior to visit one (with the exception of the AIBL trial and behavioural interventions). Participants enrolled in clinical trials involving vitamins, herbal or dietary products may be eligible on a case-by-case following discussion with the medical monitor.
研究者
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