跳至主要内容
临床试验/NCT05003830
NCT05003830招募中不适用

Application of Multi-probe PET/MR Imaging in the Diagnosis and Evaluation of Alzheimer's Disease

Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
130
试验地点
1
主要终点
Multi-modal PET/MR imaging mode in Alzheimer's disease

研究概览

简要总结

Alzheimer's disease (AD) is the most common cause of cognitive impairment, and its diagnosis requires a comprehensive analysis of the results of medical history, neuropsychological evaluation, imaging and laboratory tests. Among them, it has been widely recognized that amyloid PET imaging is used in the early diagnosis of AD, tau protein PET imaging is used in the assessment of the progression of AD, and the glucose metabolism PET imaging is used in the assessment of nerve damage. MRI can provide structure, blood perfusion, neural network connection damage and other information through multi-sequence scans. With the help of the PET/MR multi-modal imaging platform and multi-probe imaging technology, it can provide more sensitive and accurate imaging information for early diagnosis and disease assessment of AD, and provide a basis for clinical treatment decision-making.

详细描述

Cognitive impairment is a common neurodegenerative disease. The incidence of Alzheimer's disease (AD) in people over 65 years old is close to 5%, which brings a heavy burden to society. Relying only on medical history and neuropsychological evaluation, the early diagnosis and differential diagnosis of AD are difficult, and further imaging and laboratory tests are needed. This project will use PET/MRI, the most advanced imaging platform, to design a prospective clinical research program, combined with multi-sequence MRI and multi-probe PET imaging, to evaluate suspected or diagnosed AD patients. Through multi-parameter analysis of the structure MRI, function MRI (3D ASL, BOLD, DTI), metabolism PET (18F-FDG) , Aβ (11C-PIB) and tau (18F-PM-PBB3) PET, combined with clinical information, to evaluate the value of multi-modal imaging for early diagnosis and differential diagnosis of AD, to assist the clinic in the adjustment of early intervention measures and treatment strategies.

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
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who meet the core clinical diagnostic criteria for Alzheimer's disease as defined by NIA-AA for mild cognitive decline or probable Alzheimer's disease.
  • Subjects are able to understand and sign the informed consent voluntarily, with good compliance.

排除标准

  • Have contraindications to PET/MR examination.
  • Clinically clear history of stroke.
  • Have a history of bipolar disorder or depression.
  • Patients with severe heart, liver, and kidney dysfunction.
  • Pregnant or lactating women.
  • Patients refuse to sign the informed consent.

结局指标

主要结局

Multi-modal PET/MR imaging mode in Alzheimer's disease

时间窗: 2 years

Subjects with suspected or confirmed Alzheimer's disease who have completed multi-modal multi-probe PET/MR imaging, compare with healthy control group to determine the image mode of AD.

Correlation between the results of 18F-PM-PBB3 PET/MR imaging and Alzheimer's disease progression.

时间窗: 2 years

Analyze the difference in 18F-PM-PBB3 deposition area and quantitative results in patients with different severity of Alzheimer's disease.

次要结局

未报告次要终点

研究者

发起方
Wuhan Union Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaoli Lan

Director of the Department of nuclear medicine

Wuhan Union Hospital, China

研究点 (1)

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