NCT03058965已完成早期 1 期
Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Probable Alzheimer's Disease or Progressive Supranuclear Palsy Compared With Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-958 binding/uptake and expressed in SUV by using established methods for normalization for 3 AD, 3 PSP, and 3 HV subjects.
研究概览
简要总结
The overall goal of this imaging trial is to evaluate [18F]MNI-958, a tau targeted PET radioligand, in individuals with Alzheimer's disease (AD), Progressive Supranuclear Palsy (PSP), and healthy volunteers (HV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Current or prior history of any alcohol or drug abuse.
- •Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
- •Subject has received an investigational drug or device within 30 days of screening
- •Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines
- •Pregnancy, lactating or breastfeeding.
- •Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
- •Unsuitable veins for repeated venipuncture.
- •MRI exclusion criteria include: evidence of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct >1cm3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the FLAIR sequence that is ≥20 mm in any dimension), infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with CNS disease.
- •Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
- •Exclusion Criteria for Subjects with Probable AD:
- •Has received treatment that targeted amyloid-β or tau within the last 3 months.
- •Exclusion Criteria for Subjects with Probable PSP:
- •Ongoing treatment with methylphenidate, bupropion, modafinil, metoclopramide, alpha methyldopa, reserpine, or amphetamine derivative.
研究组 & 干预措施
[18F]MNI-958
Experimental
To evaluate [18F]MNI-958, a tau targeted PET radioligand.
干预措施: [18F]MNI-958 (Drug)
[18F]MNI-958
Experimental
To evaluate [18F]MNI-958, a tau targeted PET radioligand.
干预措施: [18F]Florbetapir (Drug)
[18F]MNI-958
Experimental
To evaluate [18F]MNI-958, a tau targeted PET radioligand.
干预措施: DaTscan (Drug)
结局指标
主要结局
Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-958 binding/uptake and expressed in SUV by using established methods for normalization for 3 AD, 3 PSP, and 3 HV subjects.
时间窗: 1 year
Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MNI-958.
次要结局
未报告次要终点
研究者
研究点 (1)
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