EUCTR2012-001599-12-NL进行中（未招募）1 期
The clinical value of amyloid imaging with [18F]-AV45 in a population of memory clinic patients - Clinical value AV-45
VU University Medical Center (VUmc)0 个研究点目标入组 170 人开始时间: 2014年2月17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
- 入组人数
- 170
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
- •Written informed consent; - weight >50 kg; - Mini Mental State Examination score = 18.
- •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 140
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Patients who
- •1. Have a current clinically significant psychiatric condition that neurologists/geriatricians feel would preclude the ability to have a research PET scan;
- •2. Have Acquired Immune Deficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV);
- •3. Are women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Women of childbearing potential must not be pregnant (negative urine ß-hCG at the time of screening and negative urine ß-hCG on the day of imaging) or breast feeding at screening. Women must avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable contraceptive methods such as prescribed birth control or IUD for 24 hours following administration of florbetapir (18F);
- •4. Have 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. If a subject has a history of severe drug allergies, it may be dangerous for them to participate in a study with a novel compound);
- •5. Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, ?-secretase or ?-secretase inhibitor) unless it can be documented that the subject received only placebo during the course of the trial;
- •6. Have donated blood within 3 months prior to the florbetapir (18F) PET scan day;
- •7. Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
- •8. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
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