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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06148233
• Other study ID #: KY2023-780
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: September 14, 2024

Study information

• Verified date: November 2023
• Source: Huashan Hospital
• Contact: Yihui Guan, MD
• Phone: 13764308300
• Email: guanyihui[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 14, 2024
• Est. primary completion date: June 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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 Aß 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 Aß 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Neurodegenerative Diseases
• Positron Emission Tomography

Intervention

Radiation:
• [18F]CSF-23
Intravenous injection of 1.8 MBq [0.05MCi]/kg of [18F]CSF-23 in a single dose.

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete PET imaging	To assess the diagnostic value of [18F]CSF-23 brain imaging for CSF1R expression in Alzheimer's disease.	90mins from time of injection