Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Test-Retest Reproducibility
研究概览
简要总结
This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers, MCI and AD subjects provide the same results.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
- •Male or female subjects ≥ 50 years of age
- •Mini-mental state examination (MMSE) ≥ 29
- •MCI Subjects
- •Male or female subjects ≥ 50 years of age
- •MMSE ≥ 24
- •Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD
- •Have a study partner that can report on subject's activities of daily living
- •Probable AD Subjects
- •Male or female subjects ≥ 50 years of age
- •MMSE > 10
- •Meet clinical criteria for probable AD based on the NIA-AA working group's diagnostic guidelines for AD
- •Have a study partner that can report on subject's activities of daily living
排除标准
- •Current clinically significant psychiatric disease
- •Evidence of structural brain abnormalities
- •Evidence of dementing illness other than AD
- •Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
- •Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- •History of alcohol or substance abuse or dependence
- •Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- •Have received or participated in a trial with investigational medications in the past 30 days
- •have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
研究组 & 干预措施
Healthy Volunteer Subjects
Healthy males or females 50 years or older with no evidence of cognitive impairment
干预措施: Brain PET scan (Procedure)
Healthy Volunteer Subjects
Healthy males or females 50 years or older with no evidence of cognitive impairment
干预措施: Flortaucipir F18 (Drug)
MCI subjects
Subjects 50 years or older with mild cognitive impairment (MCI)
干预措施: Flortaucipir F18 (Drug)
MCI subjects
Subjects 50 years or older with mild cognitive impairment (MCI)
干预措施: Brain PET scan (Procedure)
Probable AD Subjects
Subjects 50 years or older with probable Alzheimer's Disease (AD)
干预措施: Flortaucipir F18 (Drug)
Probable AD Subjects
Subjects 50 years or older with probable Alzheimer's Disease (AD)
干预措施: Brain PET scan (Procedure)
结局指标
主要结局
Test-Retest Reproducibility
时间窗: 110-130 minutes postdose
Evaluate test-retest reproducibility of 18F-AV-1451 for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects
次要结局
未报告次要终点