CSF1R PET Probe [18F]CSF-23 in Alzheimer's Disease Brain Imaging

Launched by HUASHAN HOSPITAL · Nov 19, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a special brain imaging technique called PET (Positron Emission Tomography) using a tracer named \[18F\]CSF-23 to help understand Alzheimer's disease better. The goal is to see how well this imaging can show a specific protein called CSF1R in the brains of people with Alzheimer's. By doing this, researchers hope to improve the way Alzheimer's is diagnosed and monitored.

To participate in the trial, you need to be between 60 and 80 years old. If you are a healthy control, you must be cognitively normal, meaning you don’t have any significant memory or thinking problems. For those with Alzheimer's, you must have a confirmed diagnosis and certain brain imaging results. Participants will need to give consent, undergo some health checks, and be willing to follow the study procedures. This trial is currently recruiting, so there’s an opportunity to contribute to important research that could help improve understanding and treatment of Alzheimer's disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Non-diseased controls:
• • 1. Between 60 and 80 years of age; gender is not limited.
• • 2. 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.
• • 3. No neurological diseases, major chronic diseases, malignant tumors, or acute infectious diseases, as determined by the investigator.
• • 4. Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
• • 5. 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.
• • 6. 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.
• • 7. Willingness and ability to cooperate with all programs of this study.
• AD patients:
• • 1. Age between 60 and 80 years old; gender is not limited.
• • 2. Patients meet the 2011 NIA-AA diagnostic criteria for red AD patients and have positive Aβ images.
• • 3. Brain MRI supported the diagnosis of AD and there was no evidence of other neurological diseases.
• • 4. No neurological diseases, major chronic diseases, malignant tumors or acute infectious diseases, etc., as confirmed by the investigator.
• • 5. Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
• • 6. 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.
• • 7. 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.
• • 8. Willingness and ability to cooperate with all programs of this study.
• Exclusion Criteria:
• * Subjects meeting any of the following criteria will be excluded from the study:
• • 1. Severe hepatic or renal insufficiency;
• • 2. 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.
• • 3. Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
• • 4. History of serious surgery in the last month.
• • 5. Participation in other clinical trials during the same period.