EUCTR2016-003451-30-ES进行中(未招募)1 期
Subjects with subjective cognitive decline: 18F-Florbetaben Positrón Emission Tomography Study. - Euro-SCD-FBB2
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)0 个研究点目标入组 30 人开始时间: 2016年12月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 30
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. According to the principal investigator, participants must be committed to participate and complete all study procedures.
- •2. The patient must report a memory problem (in isolation or in combination with complaints in other domains) with concern.
- •3. Age >/= 60*.
- •4. MMSE cutoff for inclusion will be = 26.
- •5. CDR<0.5.
- •6. Has signed the Informed Consent Form voluntarily to participate in the study.
- •* Women of childbearing potential must agree to sexual abstinence, barrier or hormonal contraceptive methods during the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Subjects those are not able to complete the study.
- •2. Any major disease or history of a major disease, especially hepatobilliar disease (AST /ALT = 5 x ULN) or advanced renal insufficiency (creatinine = 2 x ULN).
- •3. Current or previous history of alcohol abuse or epilepsy.
- •4. Allergic to Florbetaben or any of its constituents.
- •5. Multiple drug allergies and/or previous history of contrast allergy.
- •6. Any disease or history of disease which, in the opinion of the investigator, can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function).
- •7. Evidence for any other neurological or psychiatric disease, eg. parkinsonism, history of stroke or seizure.
- •8. Pregnancy or breast feeding or planned pregnancy during the study period.
研究者
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