Neuroinflammation, White Matter Integrity, AD Biomarkers and Pathology in Corticobasal Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The investigators will use C-11 ER176 PET imaging to evaluate neuroinflammation and white matter integrity in CBS
研究概览
简要总结
The primary goal of this study is to investigate inflammation and white matter damage in corticobasal syndrome and determine whether these processes are related to each other. The investigator's will address our goal by using neuroimaging and blood plasma biomarkers, as well as molecular pathology.
详细描述
Corticobasal syndrome (CBS) is a neurodegenerative disorder characterized by cognitive and behavioral change, as well as asymmetric parkinsonism, dystonia, myoclonus, and limb apraxia. Emerging evidence suggests neuroinflammation plays a key role in the pathogenesis of neurodegenerative disease, including the 4R tauopathies and AD, and neuroinflammation has been linked mechanistically to damage of the white matter. The primary goal of this study is to investigate inflammation and white matter damage using imaging and blood samples.
The investigator's will use the PET ligand 11C-ER176 to assess patterns of neuroinflammation in the brain and Neurite Orientation Dispersion and Density Imaging (NODDI) to measure white matter microstructure, including axonal density and alignment. The investigator's will also investigate blood plasma metrics, including neurofilament light chain and plasma glial fibrillary acidic protein (GFAP) that measure neuroaxonal injury and astrogliosis, and inflammation and tau metrics. The investigator's will employ beta-amyloid (A) and tau (T) PET to subdivide the CBS patients into those with biomarker AD (A+T+, CBS-AD) and those without biomarker AD (CBS-4R). The investigator's will also compare these groups to disease controls with typical amnestic biomarker AD (Amn-AD) and healthy controls (HC) that have previously been recruited for other grants (existing data collected under approved IRBs).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Age 18 years or older
- •Meet possible or probable CBS criteria
排除标准
- •Subjects will be excluded if MRI is contraindicated (due to implanted device, severe claustrophobia, etc)
- •Subjects will be excluded if they have a concurrent illnesses or structural abnormality that could account for the CBS syndrome
- •Subjects will be excluded if they have a mutation in the progranulin gene
- •Subjects will excluded if they have received anti-Aβ therapy
- •Women who are pregnant will be excluded
- •Subjects will be excluded if they are actively taking daily anti-inflammatory medications (NSAIDs, corticosteriods, etc)
- •Subjects will be excluded if they have generalized inflammatory condition and treatment with immunosuppressive, corticoid/glucocorticoid, steroidal or non-steroidal anti-inflammatory medication within 2 weeks of scanning
研究组 & 干预措施
Corticobasal Syndrome
patients diagnosed with cbs
干预措施: AV1451 Tau (Diagnostic Test)
Corticobasal Syndrome
patients diagnosed with cbs
干预措施: C-11 ER176 Radiotracer (Diagnostic Test)
Healthy Control
Healthy Control Volunteer
干预措施: C-11 ER176 Radiotracer (Diagnostic Test)
Healthy Control
Healthy Control Volunteer
干预措施: AV1451 Tau (Diagnostic Test)
Healthy Control
Healthy Control Volunteer
干预措施: C-11 PiB (Diagnostic Test)
Corticobasal Syndrome
patients diagnosed with cbs
干预措施: C-11 PiB (Diagnostic Test)
结局指标
主要结局
The investigators will use C-11 ER176 PET imaging to evaluate neuroinflammation and white matter integrity in CBS
时间窗: approximately 4-5 years into study visits
Measure whether regional patterns of ER176-PET uptake and white matter microstructure abnormalities using NODDI differ between CBS-4R, CBS-AD, Amn-AD, and HC.
次要结局
- the investigators will use blood samples to assess inflammatory and tau blood plasma metrics in CBS.(approximately 4-5 years into study visits)
研究者
Jennifer Whitwell
Associate Consultant II
Mayo Clinic