A Multicenter, Multicountry Study to Calibrate Florbetapir (18F) PET Imaging Data to the Centiloid Scale Based on 11C-PiB
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Florbetapir SUVr Conversion to Centiloid Units
研究概览
简要总结
This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cognitively Normal Subjects
- •Males or females ≥ 21 and ≤ 45 years of age
- •Mini-mental state examination (MMSE) ≥ 29
- •Clinically Diagnosed AD Subject
- •Males or females ≥ 50 years of age
- •Meet clinical criteria for dementia due to probable AD
- •MMSE ≥ 16 and ≤ 26
- •Possible AD Subject
- •Males or females ≥ 50 years of age
- •Meet clinical criteria for dementia due to possible AD
- •MMSE ≥ 16 and ≤ 26
- •MCI Subject
- •Males or females ≥ 60 years of age with cognitive impairment (not dementia)
- •MMSE >24 and <29
- •At Risk Elderly Subject
- •Cognitively normal males or females that are known ApoE4 carriers and ≥ 75 years of age
- •MMSE ≥ 27
排除标准
- •Have had or currently have a diagnosis of neurodegenerative disorders other than AD
- •Have a current serious or unstable illness that could interfere with completion of the study
- •Subject has a known brain lesion, pathology or traumatic brain injury
- •Have received or participated in a trial with investigational medications in the past 30 days
- •Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session
- •Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
研究组 & 干预措施
Amyloid Negative Subjects
Approximately 10 cognitively normal young subjects will receive a single i.v. bolus injection of approximately 370 megabecquerel (MBq) (10 millicurie [mCi]) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.
干预措施: Florbetapir (18F) (Drug)
Amyloid Negative Subjects
Approximately 10 cognitively normal young subjects will receive a single i.v. bolus injection of approximately 370 megabecquerel (MBq) (10 millicurie [mCi]) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.
干预措施: 11C-PiB (Drug)
Amyloid Positive Subjects
Approximately 25 subjects with a range of amyloid density comprised of subjects clinically diagnosed with Alzheimer's Disease (AD) and subjects at risk for elevated amyloid density will receive a single i.v. bolus injection of approximately 370 MBq (10 mCi) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.
干预措施: Florbetapir (18F) (Drug)
Amyloid Positive Subjects
Approximately 25 subjects with a range of amyloid density comprised of subjects clinically diagnosed with Alzheimer's Disease (AD) and subjects at risk for elevated amyloid density will receive a single i.v. bolus injection of approximately 370 MBq (10 mCi) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.
干预措施: 11C-PiB (Drug)
结局指标
主要结局
Florbetapir SUVr Conversion to Centiloid Units
时间窗: up to 70 minutes post injection
Conversion of florbetapir (18F) positron emission tomography (PET) standard uptake value ratio (SUVr) to Centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (\<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.
次要结局
- Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid(up to 70 minutes post injection)
- Variability of PET Images in Young Healthy Control Subjects.(up to 70 minutes post injection)