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临床试验/EUCTR2014-000763-41-ES
EUCTR2014-000763-41-ES进行中(未招募)1 期

Study of genetic Alzheimer?s disease mutation carriers in preclinical stages of the disease: 18F-Florbetaben Positron Emission Tomography study.

FUNDACIÓ CLÍNIC PER A LA RECERCA BIOMÈDICA0 个研究点目标入组 40 人开始时间: 2014年7月22日最近更新:
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
40

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. Adult children (> 18 yo) of genetic Alzheimer?s disease
  • patients with a known mutation in PSEN1, APP o PSEN2
  • genes and who are either cognitively normal (CDR=0) or
  • have mild symptoms of cognitive decline (CDR 0.5 or 1)
  • 2. According to the principal investigator, participants must
  • be committed to participate and complete all study
  • procedures.
  • 3. Has signed the Informed Consent Form voluntarily to
  • participate in 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 40
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. Subjects that 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
  • 6. Pregnancy or breast feeding or planned pregnancy during
  • the study period
  • 7. 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)
  • 8. Evidence for any other neurological or psychiatric disease

研究者

发起方
FUNDACIÓ CLÍNIC PER A LA RECERCA BIOMÈDICA

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