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临床试验/EUCTR2014-001014-25-ES
EUCTR2014-001014-25-ES进行中(未招募)1 期

Brain Amyloid-Beta burden as per florbetaben (Neuraceq) pet and cognitive outcomes after deep brain stimulation in Parkinsin's disease

Fundació Clínic per la Recerca Biomèdica0 个研究点开始时间: 2016年7月15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

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

性别
All

入选标准

  • 1.PD patients aged 60 to 69 years,
  • 2.Motor fluctuations refractory to the best medical treatment that have led to the indication of STN-DBS;
  • 3.Commitment to participate and complete all study procedures according to the principal investigator;
  • 4.Voluntary fulfilment and signature of the study Informed Consent Form.
  • 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 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 30

排除标准

  • 1.Subjects not eligible for STN-DBS (due to presence of one or more exclusion criteria for STN-DBS including the possibility of a diagnosis different to PD, such as any of the atypical parkinsonisms) or likely not to be able to complete the study;
  • 2.PD-related dementia according to the MDS definition of PD-dementia;
  • 3.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);
  • 4.Current or previous history of alcohol abuse or epilepsy;
  • 5.Allergy to FBB or any of its constituents;
  • 6.Multiple drug allergies and/or previous history of contrast allergy;
  • 7.Pregnancy or breast feeding or planned pregnancy during the study period;
  • 8.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);
  • 9.Evidence for any other neurological or psychiatric disease.

研究者

发起方
Fundació Clínic per la Recerca Biomèdica

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