Biodistribution, Pharmacokinetics, and Safety of F-18 THK-5351 PET in Alzheimer's Disease Patients and Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- The primary outcome measures are to evaluate the dosimetry of novel radiotracer F-18 THK-5351 in human.
研究概览
简要总结
Biodistribution, pharmacokinetics, and safety of F-18 THK-5351 PET in Alzheimer's disease patients and healthy subjects.
详细描述
Totally 24 subjects age 20-90 including 12 healthy cognitively intact subjects and 12 probably Alzheimer's dementia patients with NINCDS-ADRDA criteria. For disease subjects, caregiver should be able to report activities of daily living and their mental status. Patient should be able to give informed consent or have a caregiver give consent with subject assent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neurologic testing. (MMSE 24-30, Wechsler Logical Memory score >5).
- •Subjects must provide written inform consent.
- •Patients with AD Inclusion Criteria:
- •Diagnosis of AD according to the clinical diagnostic criteria of "possible AD" with NINCDS-ADRDA criteria
- •MMSE 20-26, Clinical dementia rating 0.5 or 1, Wechsler Logical Memory score<=4
- •Patient who provide a written informed consent prior to study entry. (If the patient is incapable informed consent, the caregiver may consent on behalf of the patient. The caregiver should be able to report activities of daily living and their mental status.)
排除标准
- •Pregnant or become pregnant
- •Current breast feeding
- •Clinically significant abnormal laboratory values
- •Unstable medical or psychiatric illness.
- •Cardiovascular disease (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease).
- •History of drug or alcohol abuse within the last year, or prior prolonged history of abuse. --History of severe allergic or anaphylactic reactions particularly to the tested drugs .
- •PI assessment with high risk.
研究组 & 干预措施
F-18 THK-5351
F-18 THK-5351 imaging
干预措施: F-18 THK-5351 (Drug)
结局指标
主要结局
The primary outcome measures are to evaluate the dosimetry of novel radiotracer F-18 THK-5351 in human.
时间窗: One year
Time-integrated activity in each organ will be calculated by trapezoidal integration of the first 45 min of the organ's time-activity curve, followed by a single-exponential fit to the remaining data points (based on the 4 whole-body images) extrapolate to infinity, all base on non-decay-corrected data.Residence times will be obtained by dividing the time-integrated activity by the injected amount of activity.
次要结局
- Optimal scanning time for brain imaging using F-18 THK-5351.(One year)