EUCTR2014-003047-35-NL进行中（未招募）1 期
Evaluation of 18F-AV-1451 kinetic modeling in patients in Alzheimer's disease and healthy controls
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
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
- •HC Subjects:
- •- Male or female = 50 years of age
- •- No evidence of cognitive impairment
- •AD subjects:
- •- Male or female = 50 years of age
- •- Clinical diagnosis of probable AD
- •- MMSE = 18
- •- PET or CSF biomarker data supports that the subject is amyloid positive
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •All subjects:
- •- Current clinically significant psychiatric condition
- •- MRI evidence of brain structural abnormality
- •- History of moderate or severe traumatic brain injury
- •- Hemoglobin = 8 in males or = 7 in females
- •- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- •- Relevant history of severe drug allerfy or hypersensitivity
- •- Current clinically significant cardiovascular disease, abnormalities on screening ECG (e.g. QTc > 450 msec), a history of additional risk factors for Torsades de Pointes, or are taking drugs known to cause QT-prolongation
- •- Donated blood within 6 months
- •- Recieved investigational medications or participated in a trial with investigational medications within 30 days
- •- 18F-AV-1451 PET imaging procedure will occur within 6 terminal half-lives of a previously administered radiopharmaceutical
研究者
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