EUCTR2015-003045-26-SE进行中（未招募）1 期
[18F] FE-PE2I PET/CT study of Dopamine Transporters in Early Parkinsonian disease.
meå University Hospital0 个研究点目标入组 105 人开始时间: 2015年9月15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
- 105
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
- •Inclusion criteria for patients
- •-Woman or man, age 45-80 years who has given written informed consent to participate in the study
- •- For a woman in childbearing age: Negative pregnancy test in connection with inclusion and consent to the use of effective contraception (the so-called Pearl index < 1 in accordance with the Medical Products Agency recommendations) , or abstinence until 24 hours after [ 18F ] FE PE2I PET / CT respectively . 72h after DaTSCAN ™ SPECT / CT.
- •The following contraceptive methods provide, when used properly , a so-called Pearl index < 1: combined pills or middle-dosed gestagen oral contraceptive pills (not mini-pills ) , intra-uterine device ( IUD or IUS ) , implants , vaginal ring , contraceptive injection or transdermal patch . Female sterilization (bilateral tubarocklusion ) or sterilized male partner ( vasectomy ) is also accepted .
- •-Idiopathic Parkinsonism according to UK PDSBB clinical criteria for parkinsonism:
- •Bradykinesia + At least two of these:
- •Muscular rigidity
- •4-6 Hz resting tremor
- •-Postural Instability (not primary visual / vestibular / proprioceptive dysfunction)
- •-Clinical diagnosis during the period of inclusion = idiopathic parkinsonism (NB not previously known diagnosis)
- •-At the time of Inclusion permanent reside in the county of Västerbotten.
- •Inclusion criteria for healthy subjects:
- •-Woman or man, age =60-80 years who has given written informed consent to participate in the study
- •-Subjective in generally good health for his/her age
- •-Objective generally good health.
- •-No known or suspected present disease of the nervous system (neurological or psychiatric)
- •-At the time of Inclusion permanent reside in the county of Västerbotten.
- •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 75
排除标准
- •Principal exclusion criteria (list the most important, max 5000 characters)
- •-Severe ongoing medical condition that can be predicted to impair full participation in the study (e.g. treatment of cancer)
- •- Disease which prevents imaging (eg PET/CT, SPECT and MR) in prone position (e.g. severe heart failure, severe backache)
- •- History of stroke, TIA or known other serious neurological / neurodegenerative disorders (e.g., brain tumor, multiple sclerosis, ALS)
- •- Secondary parkinsonism (e.g. drug-induced Parkinsonism or obvious vascular parkinsonism)
- •-Known hypersensitivity to iodine
- •-Claustrophobia or other contraindication for MRI (e.g pacemaker or magnetic implant etc)
- •-Depression or other severe psychiatric condition in need of treatment (psychosis or similar severity)
- •-Dementia or MMSE <24
- •-Severe hypertension (> 180/110 mmHg)
- •-History of drug abuse (e.g. central stimulants or alcohol; nicotine use excepted)
- •-Pregnancy or breast-feeding
- •-Not willing to participate in the study
研究者
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