NCT07114224尚未招募不适用
Aβ PET and Tau PET Imaging in the Diagnosis and Progression Assessment of Alzheimer's Disease
Xijing Hospital0 个研究点目标入组 70 人开始时间: 2025年8月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- SUVmean
研究概览
简要总结
This prospective study recruited 20 healthy volunteers and 50 patients diagnosed with Alzheimer's disease (AD) and mild cognitive impairment (MCI) according to clinical guidelines. Participants underwent AV45/AV-1 and AV1451 PET imaging to obtain information on Aβ protein deposition, tau protein distribution, and structural and functional information. The study aims to evaluate the value of multimodal imaging features in the diagnosis and progression assessment of AD, providing imaging evidence for novel treatment modalities such as lecanemab therapy and deep cervical vein-lymphatic anastomosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-75 years old; Healthy volunteers: males weighing ≥50 kg, females weighing ≥45 kg, with a body mass index (BMI = weight (kg)/height² (m²)) within the range of 19.0-28.0 kg/m² (including boundary values); Cognitive disorders diagnosed clinically according to guidelines include Alzheimer's disease (AD) and mild cognitive impairment (MCI). Diagnostic criteria are as follows: 1) Clinical manifestations include symptoms such as memory impairment, difficulty concentrating, slowed thinking, and poor language skills; 2) Neuropsychological tests show that functions such as memory, attention, thinking, and language are below the normal population level; 3) Blood or cerebrospinal fluid tests show elevated levels of human β-amyloid 1-42, human β-amyloid 1-40, and human phosphorylated tau protein. 4) Exclusion of other factors that may cause cognitive impairment, such as drug or substance abuse, environmental factors, etc.; Signing an informed consent form for PET/MR or PET/CT examinations and voluntarily participating in this study.
排除标准
- •Minors, pregnant women, breastfeeding women, individuals with severe liver or kidney dysfunction, and those with a history of allergy to contrast agents or other medications; Diagnosed with viral encephalitis, acute myelitis, idiopathic epilepsy, or antibody-negative AIE; Diagnosed with any major illness; history of alcohol or drug abuse/dependence; History of cardiovascular disease, tumours, blood disorders, or poorly controlled chronic conditions; Contraindications for PET/MR imaging. History of head trauma or surgery; History of other neurological disorders.
结局指标
主要结局
SUVmean
时间窗: 1 hour from injection of the tracer
mean of standardized uptake value
VOI
时间窗: 1 day from injection of the tracer
volume of interest
次要结局
未报告次要终点
研究者
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