PET Imaging of Neuroinflammation in Neurodegenerative Diseases Via a Novel TSPO Radioligand
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
研究概览
简要总结
Background:
Aging-related progressive neurological disorders include frontotemporal dementia, Lou Gehrig s disease, and Alzheimer s disease. Little is known about what causes these disorders. Brain inflammation may be involved. Researchers want to see if scans using radioactive drugs can show brain inflammation.
Objective:
To see if the drug [11C]ER176 can show inflammation in the brain in people with certain progressive neurological disorders compared to healthy adults. Also to find genes that might be associated with or cause these disorders.
Eligibility:
People ages 18 and older with an aging-related neurological disorder, and healthy adults
Design:
Participants will be screened with a medical history, physical exam, neurological exam, psychiatric history, and blood tests.
Participants will have 2-5 visits for the first session. They will have 2 PET scans and 1 MRI scan. They may have 3 more sessions: 6 months to about 18 months later, 1 year after that, and about 30 months to 5 years after the first visit. There may be up to 20 total visits.
For the scans, participants will lie on a bed that slides into the scanners. For the PET scans, a strap will fix their head in place. A radioactive drug will be injected through a catheter. A needle will guide a thin plastic tube into an arm vein. Additional catheters may be put in place to draw blood. Each PET will take 2 hours. The MRI will take 30 60 minutes.
At each session, participants will have a brief interview, medical history, physical exam, blood and urine tests, heart tests, and memory and thinking tests. They may donate blood for DNA tests.
详细描述
Objectives
The primary objective is to explore if human subjects with neurodegenerative diseases exhibit different level of neuroinflammation, as measured by brain uptake of a 3rd generation [11C]ER176 TSPO ligand, compared to control subjects. The secondary objectives are to determine, 1) if [11C]ER176 TSPO brain uptake shows disease-specific patterns across different neurodegenerative diseases and/or genetic mutations, and 2) if longitudinal imaging of individual patients shows a correlation between interval change of tracer uptake and disease progression.
Study population
Adults referred with a clinical diagnosis or with an increased risk of frontotemporal dementia, amyotrophic lateral sclerosis, Alzheimer s disease, other related adult-onset neurodegenerative disorders, or healthy control subjects.
Design
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(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
- 未提供
研究组 & 干预措施
Healthy volunteers
Participants underwent brain positron emission tomography (PET) scan with [11C]ER176 and/or [11C]PIB followed by brain magnetic resonance imaging (MRI)
干预措施: 11C-ER176 (Drug)
Healthy volunteers
Participants underwent brain positron emission tomography (PET) scan with [11C]ER176 and/or [11C]PIB followed by brain magnetic resonance imaging (MRI)
干预措施: 11C-PIB (Drug)
Healthy volunteers
Participants underwent brain positron emission tomography (PET) scan with [11C]ER176 and/or [11C]PIB followed by brain magnetic resonance imaging (MRI)
干预措施: Positron Emission Tomography (PET) Scan (Diagnostic Test)
Subjects with chromosome 9 open reading frame 72 (C9ORF72)
Participants underwent brain positron emission tomography (PET) scan with [11C]ER176 and/or [11C]PIB followed by brain magnetic resonance imaging (MRI)
干预措施: 11C-ER176 (Drug)
Subjects with chromosome 9 open reading frame 72 (C9ORF72)
Participants underwent brain positron emission tomography (PET) scan with [11C]ER176 and/or [11C]PIB followed by brain magnetic resonance imaging (MRI)
干预措施: 11C-PIB (Drug)
Subjects with chromosome 9 open reading frame 72 (C9ORF72)
Participants underwent brain positron emission tomography (PET) scan with [11C]ER176 and/or [11C]PIB followed by brain magnetic resonance imaging (MRI)
干预措施: Positron Emission Tomography (PET) Scan (Diagnostic Test)
Subjects with Frontotemporal dementia (FTD)
Participants underwent brain positron emission tomography (PET) scan with [11C]ER176 and/or [11C]PiB followed by brain magnetic resonance imaging (MRI)
干预措施: 11C-ER176 (Drug)
Subjects with Frontotemporal dementia (FTD)
Participants underwent brain positron emission tomography (PET) scan with [11C]ER176 and/or [11C]PiB followed by brain magnetic resonance imaging (MRI)
干预措施: 11C-PIB (Drug)
Subjects with Frontotemporal dementia (FTD)
Participants underwent brain positron emission tomography (PET) scan with [11C]ER176 and/or [11C]PiB followed by brain magnetic resonance imaging (MRI)
干预措施: Positron Emission Tomography (PET) Scan (Diagnostic Test)
结局指标
主要结局
Standard Uptake Value Ratio Compared to the Cerebellum (SUVR) Area Under the Curve (AUC) (60-90min)
时间窗: Up to 90 minutes during scan
Participants underwent brain positron emission tomography (PET) scan with \[11C\]ER176 and standard uptake value (SUV) was measured over 90 minutes and divided by SUV of the cerebellum to determine difference of \[11C\]ER176 brain uptake
次要结局
未报告次要终点
