NCT06148233招募中不适用
CSF1R PET Probe [18F]CSF-23 in Alzheimer's Disease Brain Imaging
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Complete PET imaging
研究概览
简要总结
To explore the diagnostic value of [18F]CSF-23 brain imaging for CSF1R expression in Alzheimer's disease. PET imaging with this PET tracer was used to assess the role and expression of CSF1R in AD and to evaluate the level and safety of abnormal present imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-diseased controls:
- •Between 60 and 80 years of age; gender is not limited.
- •Cognitively normal as determined by the investigator through testing, with an MMSE score greater than 25 and no cognitive domain impairment. They had a negative Aβ image.
- •No neurological diseases, major chronic diseases, malignant tumors, or acute infectious diseases, as determined by the investigator.
- •Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
- •Blood routine: white blood cell count (WBC) 4~10×109/L; platelet (PLT) 100~300×109/L; hemoglobin (HB) 120~160 g/L; renal function: serum creatinine less than or equal to the upper limit of the normal range; hepatic function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range; Electrocardiogram: no significant abnormalities.
- •No neurological diseases, major chronic diseases, malignant tumors, or acute infectious diseases, as confirmed by the investigator; no family history of neurodegenerative movement disorders, and no family history of neurological disorders related to movement disorders.
- •Willingness and ability to cooperate with all programs of this study.
- •AD patients:
- •Age between 60 and 80 years old; gender is not limited.
- •Patients meet the 2011 NIA-AA diagnostic criteria for red AD patients and have positive Aβ images.
- •Brain MRI supported the diagnosis of AD and there was no evidence of other neurological diseases.
- •No neurological diseases, major chronic diseases, malignant tumors or acute infectious diseases, etc., as confirmed by the investigator.
- •Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
- •Blood routine: white blood cell count (WBC) 4~10×109/L; platelet (PLT) 100~300×109/L; hemoglobin (HB) 120~160 g/L; renal function: serum creatinine less than or equal to the upper limit of the normal range; hepatic function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range; ECG: no significant abnormalities.
- •No neurological diseases, major chronic diseases, malignant tumors, or acute infectious diseases, as confirmed by the investigator; no family history of neurodegenerative movement disorders, and no family history of neurological disorders related to movement disorders.
- •Willingness and ability to cooperate with all programs of this study.
排除标准
- •Subjects meeting any of the following criteria will be excluded from the study:
- •Severe hepatic or renal insufficiency;
- •Participation in other research protocols or clinical care within the past year, in addition to the radiation exposure expected from participation in this clinical study, which has resulted in radiation exposure in excess of an effective dose of 50 mSv.
- •Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
- •History of serious surgery in the last month.
- •Participation in other clinical trials during the same period.
结局指标
主要结局
Complete PET imaging
时间窗: 90mins from time of injection
To assess the diagnostic value of \[18F\]CSF-23 brain imaging for CSF1R expression in Alzheimer's disease.
次要结局
未报告次要终点
研究者
研究点 (1)
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