NCT01265394已完成3 期
A Single-arm, Open-label, Multi-center Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid
研究概览
简要总结
Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this study is to determine how well the study drug performs in young healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject age is 18 to 40 years.
- •The subject has no evidence of thinking or memory problems by medical history.
- •The subject has a normal MRI scan.
- •The subject's general health is adequate to comply with study procedures.
- •The subject is willing and able to participate in all study procedures.
排除标准
- •The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT).
- •The subject has a contraindication for (cannot undergo) MRI.
- •The subject has a history of head injury with loss of consciousness.
- •The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology.
- •The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree relative.
研究组 & 干预措施
(18F) Flutemetamol
Experimental
干预措施: [18F] Flutemetamol (Drug)
结局指标
主要结局
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid
时间窗: PET scans performed on patients 90 minutes post Flutemetmol Administration
The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging. The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading).
次要结局
- Measurement of Amyloid Content in Different Parts of the Brain(PET scans performed on patients 90 minutes post Flutemetmol Administration)
研究者
研究点 (1)
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