NCT02103894已完成1 期
Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Clinically Diagnosed Tauopathies in Comparison to Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Brain uptake of [18F]T807 ([18F]MNI-777)
研究概览
简要总结
The goal of this study is to assess [18F]MNI-777 PET imaging as a tool to detect tau pathology in the brain of individuals who carry a clinical diagnosis of a tauopathy, including: Alzheimer's Disease (AD),Parkinson's disease (PD) Progressive Supranuclear Palsy (PSP), chronic traumatic encephalopathy (CTE) and Frontal Temporal Dementia (FTD) and age- and gender-matched healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For all subjects:
- •Written informed consent or assent is obtained.
- •Willing and able to cooperate with study procedures.
- •For females, non-child bearing potential or negative urine pregnancy test on day of [18F]MNI-777 injection.
- •Alzheimer Disease subjects:
- •The participant is 50 years or older.
- •Participants have a clinical diagnosis of Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria (McKann, 1984)
- •Modified Hachinski Ischemia Scale score of ≤
- •Parkinson's Disease subjects:
- •The participant is 30 years or older.
- •Participants have a clinical diagnosis of PD based on the UK Brain Bank Criteria (Hughes, et al., 1982).
- •The duration of diagnosis of PD is <20 years prior to the imaging visit
- •PD subjects must be on stable doses of medications for a period of at least 30 days prior to the imaging visit.
- •Treatment with dopamine replacement therapies or other symptomatic therapies for PD is permitted; however, subjects must be on a stable dose of medications 30 days prior to the imaging visit.
- •Progressive Supranuclear Palsy subjects:
- •The participant is 30 years or older.
- •Participants have a clinical diagnosis of PSP based on National Institute of Neurological Disorders and Stroke/ (NINDS) and the Society for PSP (SPSP) criteria (Litvan, et al. 1996).
- •Chronic Traumatic Encephalopathy subjects:
- •The participant is 18 years or older.
- •Subjects with a diagnosis of probable CTE based on a prior history of repetitive brain trauma and at least one concussion, and a current mood disorder (depression, apathy, irritability, suicidal ideation), cognitive symptoms (memory loss, impaired executive function) or behavioral symptoms (disinhibition, aggression and increased violence) (Jordan, 2013).
- •Frontal Temporal Dementia/Pick's disease subjects:
- •The participant is 50 years or older.
- •Participants have a clinical diagnosis of FTD based on consensus for clinical diagnosis of frontotemporal dementia (Neary, et al., 1998)
- •Healthy Control subjects:
- •The participant is 18 - 85 years old.
- •Negative history of neurological or psychiatric illness based on evaluation by a research physician.
- •MMSE score must be 29 or above.
排除标准
- •All subjects will be excluded from participation for the following reasons:
- •The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
- •The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
- •The subject has evidence of a structural lesion on MRI that may interfere with interpretation of PET imaging.
- •The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- •The subject has participated in another clinical study within the previous 30 days.
- •Pregnancy or women who are nursing or breastfeeding
研究组 & 干预措施
[18F]T807 ([18F]MNI-777)
Experimental
At the [18F]MNI-777 PET imaging visit, subjects will be injected with no more than 10 mCi (370 MBq) of [18F]MNI-777).
干预措施: [18F]T807 ([18F]MNI-777) (Drug)
结局指标
主要结局
Brain uptake of [18F]T807 ([18F]MNI-777)
时间窗: 2 years
To quantitatively assess the brain uptake of \[18F\]MNI-777 (\[18F\]T807), an imaging biomarker for tau pathology in brain, using positron emission tomography (PET) in individuals with clinically diagnosed tauopathies including: Alzheimer's disease (AD), Parkinson's disease (PD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE) and frontal temporal dementia/Pick's disease (FTD) and healthy controls (HC).
次要结局
未报告次要终点
研究者
Danna Jennings
Principal Investigator
Molecular NeuroImaging
研究点 (1)
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