Tau PET Imaging With 18F-T807(AV1451) in Neurodegenerative Disorders
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- standardized uptake value ratio (SUVR)
研究概览
简要总结
Alzheimer's disease, Parkinson's disease, and Huntington's disease are common neurodegenerative diseases. Tau is a microtubule-associated protein, and aggregated tau resulting from hyperphosphorylation is a pathological feature of a group of neurodegenerative diseases known as tauopathies. The 18F-T807 (AV1451) molecular probe is a novel molecularly targeted imaging agent that exhibits high affinity and good selectivity for tau.
详细描述
In this study, 18F-T807 (AV1451) molecular probe PET/CT was used to monitor the regional distribution and the degree of deposition in patients with neurodegenerative diseases, and compared with clinical symptoms to evaluate its value in the early differential diagnosis of neurodegenerative diseases.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients or their families complain of significant memory impairment;
- •Objective memory impairment (e.g., tests of article identification, recall, delayed memory);
- •Be able to obtain complete diagnosis and treatment records and be able to carry out long-term follow-up;
- •Signed written consent.
排除标准
- •Psychiatric disorders: including anxiety disorder, affective disorder, severe psychosis, or drug-induced psychosis;
- •Pregnancy or lactation.
研究组 & 干预措施
18F-T807, PET/CT
PET/CT perform after injecting 18F-T807
干预措施: 18F-T807 (Drug)
结局指标
主要结局
standardized uptake value ratio (SUVR)
时间窗: From right after tracer injection to 2-hours post-injection
the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference
Aβ42 in CSF
时间窗: Within 2 hours prior to tracer injection
Aβ42 (amyloid beta isoform 42) is significantly lower in the cerebrospinal fluid of patients with neurodegenerative diseases and is one of the biomarkers used clinically to diagnose neurodegenerative diseases
t-tau in CSF
时间窗: Within 2 hours prior to tracer injection
t-tau (total tau) is significantly increased in the cerebrospinal fluid of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration
NfL in the blood
时间窗: Within 2 hours prior to tracer injection
NfL is significantly increased in the blood of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration
NfL in CSF
时间窗: Within 2 hours prior to tracer injection
NfL (neurofilament light chain) is significantly increased in the cerebrospinal fluid of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration
p-tau in CSF
时间窗: Within 2 hours prior to tracer injection
p-tau (tau phosphorylated at Thr-181) is significantly increased in the cerebrospinal fluid of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration
次要结局
未报告次要终点
研究者
Shaobo Yao, PhD
Director of Nuclear Medicine Department
First Affiliated Hospital of Fujian Medical University