EUCTR2011-001564-21-GB进行中（未招募）1 期
Towards Onset Prevention of COGnitive decline in adults with Down syndrome (the TOP-COG study) - The TOP-COG study
HS Greater Glasgow and Clyde0 个研究点目标入组 70 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •(1) Down syndrome.
- •(2) Aged =50.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •(1) No consent obtained.
- •(2) Unable to comply with the protocol, including providing blood or saliva for baseline APO E e4 measurement, and venous or capillary blood for cholesterol measurement.
- •(3) Dementia at baseline (as the study is investigating primary prevention).
- •(4) Diabetes (as this is an indication for a prescription of a statin).
- •(5) Clinically evident atherosclerotic disease (as this is an indication for a prescription of a statin).
- •(6) Being at risk for cardiovascular disease (as this is an indication for a prescription of a statin).
- •(7) Liver disease.
- •(8) Chronic renal insufficiency.
- •(9) Being prescribed:
- •b)fibrates,
- •c)nicotinic acid,
- •d)cyclosporine,
- •e)azole antifungal,
- •f)itraconazole,
- •g)ketoconazole,
- •h)macrolide antibiotics,
- •i)erythromycin,
- •j)clarithromycin,
- •k)fusidic acid,
- •l)HIV protease inhibitors,
- •m)nefazodone,
- •n)verapamil,
- •o)amiodarone,
- •p)warfarin.
- •(10) Having previously had a statin serious adverse reaction.
- •(11) Unable or unwilling to avoid consumption of grapefruit juice.
- •(12) Excessive alcohol use (>21 units/week for men, or >14 units/week for women).
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