EUCTR2015-004230-10-NL进行中（未招募）1 期
Validating in vivo quantification of tau with [18F]AV-1451 PET - TRT-tau
VU University Medical Center0 个研究点目标入组 15 人开始时间: 2016年2月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- •A healthy control subject must meet all of the following criteria:
- •1. At least 50 years of age;
- •2. Have no evidence of cognitive impairment as indicated by a cognitive neurologist;
- •3. Subjects, who in the opinion of the principal investigator, can tolerate the [18F]AV1451 PET scan procedures.
- •Probable AD subjects must meet the following inclusion criteria:
- •1. At least 50 years of age;
- •2. Have a clinical diagnosis of probable AD (McKhann, 2011) and are part of the Amsterdam Dementia Cohort (Flier et al. 2014);
- •3. Have a Mini Mental State Examination (MMSE) of 18 or higher;
- •4. Subjects, who in the opinion of the principal investigator, can tolerate the [18F]AV-1451 PET scan and blood sampling procedures.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study if he or she:
- •1. Has contra indications for MRI scanning and therefore can not receive brain MRI
- •2. Has evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of a PET scan;
- •3. Has a history of severe traumatic brain injury (TBI);
- •4. Has a hemoglobin test (Hb) result of < 8 in males and < 7 in females;
- •5. Is a female of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant or breastfeeding at screening.
- •6. Has a relevant history of severe drug allergy or hypersensitivity (relevant severe drug allergies should be determined by the Principal Investigator or Co-Principal Investigator, and any questions about a subject’s eligibility can be directed to Avid Radiopharmaceuticals Inc.);
- •7. Has current clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG (including but not limited to QTc>450 msec). If QTc is >450 at screening, the principal investigator may consult with Avid for approval to enroll;
- •8. Has a history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT syndrome) or is taking drugs that are known to cause QT-prolongation;
- •9. Has donated blood within 6 months prior to the [18F]AV-1451 PET scan day;
- •10. Has ever participated in an experimental study with a tau or amyloid targeting agent, unless it can be documented that the subject received only placebo during the course of the trial.
- •11. Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR when total yearly radiation exposure exceeds 10 mSv.
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