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临床试验/EUCTR2016-003451-30-ES
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

发起方
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)

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