Amyloid-beta PET Imaging With 18F-92 in Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- t-tau in CSF
研究概览
简要总结
Alzheimer's disease is a neurodegenerative disease. Numerous studies have reported that β-amyloid (Aβ) is an important marker for the diagnosis of AD. 18F-92 molecular probe is a novel molecularly targeted imaging agent, which can rapidly penetrate the blood-brain barrier and has high affinity and selectivity for Aβ protein. In this study, 18F-92 PET/CT was used to monitor the regional distribution and the degree of deposition in patients with Alzheimer's disease, and compared with clinical symptoms (neuropsychometry) to evaluate its application value in the diagnosis of AD.
详细描述
Healthy volunteers as well as patients meeting Alzheimer's criteria will be recruited for this study.
We will use PET/CT imaging technology to scan each participant's whole body or head and collect image data for analysis to evaluate the distribution and metabolism of 18F-92 in the subject's body. Time from drug injection to scan completion is approximately 1 hour.
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
- 是
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);
- •Meets Alzheimer's criteria for DSMIV and NINCDS-ADRDA;
- •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
- •Nervous system diseases: including brain tumors, craniocerebral trauma, multiple sclerosis, epilepsy, etc.;
- •Psychiatric disorders: including anxiety disorder, affective disorder, severe psychosis, or drug-induced psychosis;
- •Pregnancy or lactation.
研究组 & 干预措施
18F-92, PET/CT
PET/CT perform after injecting 18F-92
干预措施: 18F-92 (Drug)
结局指标
主要结局
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 Alzheimer's disease and is one of the biomarkers used clinically to diagnose Alzheimer's disease
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 Alzheimer's disease and is one of the biomarkers used clinically to diagnose Alzheimer's disease
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
MMSE (Mini-mental State Examination)
时间窗: Within 2 hours prior to tracer injection
The commonly used neuropsychological evaluation scale in clinical practice can comprehensively reflect the intellectual status and the degree of cognitive decline of the subjects. 30 points total, lower scores represent worse cognitive function, normal: 27-30 points; cognitive dysfunction: \< 27; mild: 21-26; moderate: 10-20; severe: 0-9
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 Alzheimer's disease and is one of the biomarkers used clinically to diagnose Alzheimer's disease
MoCA (Montreal Cognitive Assessment)
时间窗: Within 2 hours prior to tracer injection
A scale used clinically for cognitive function screening, with a full score of 30, ≥ 27 being normal, 18-26 being mild cognitive impairment, 10-17 being moderate, and less than 10 being severe
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