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
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