EUCTR2012-003079-20-IT进行中（未招募）不适用
Evaluation of florbetapir (18F) PET in subjects participating in the IRCCSFBF protocol
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Subjects should have already met inclusion and exclusion criteria for the main protocol Clinical assessment and follow-up of a naturalistic population of patients enrolled in an amyloid imaging program in Memory Clinics in Brescia, Italy”, that are: a) Patients with cognitive complaints who will be included in a diagnostic work-up to make a differential diagnosis; b) Age between 50 and 85 years; c) Patients who have an informant (spouse, adult child, or friend who knows the patient well) available for accompanying to visits. In addition: Subjects meet the following inclusion criteriona: 1. Subjects who sign an Independent Ethics Committee (IEC) approved informed consent form prior to any florbetapir (18F) PET procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Subjects will be excluded from enrollment if they have already met exclusion criteria for the main protocol Clinical assessment and follow-up of a naturalistic population of patients enrolled in an amyloid imaging program in Memory Clinics in Brescia, Italy”, that are: • Are MCI patients with a CDR (Clinical Dementia rating Scale) > 0,5 at baseline; AD and non-AD patients with a CDR (Clinical Dementia rating Scale) > 2 at baseline. In addition, subjects will be excluded from enrollment if they: : a. Have a current clinically significant psychiatric condition that neurologists/geriatricians feel would preclude the ability to have a research PET scan; b. 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); c. 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); d. 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; f. Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days; and g. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
研究者
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