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

• Sponsor: Huashan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06148233
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Positron Emission Tomography; Alzheimer Disease; Neurodegenerative Diseases	Radiation: [18F]CSF-23	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: CSF1R PET Probe [18F]CSF-23 in Alzheimer's Disease Brain Imaging
• Actual Study Start Date: Sep 15, 2023
• Anticipated Primary Completion Date: Jun 16, 2024
• Anticipated Study Completion Date: Sep 14, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients with Alzheimer's Disease AD subjects recruited from geriatric wards or memory clinics.	Radiation: [18F]CSF-23; Intravenous injection of 1.8 MBq [0.05MCi]/kg of [18F]CSF-23 in a single dose.
Experimental: Cognitively normal control group Cognitively normal subjects recruited from the community	Radiation: [18F]CSF-23; Intravenous injection of 1.8 MBq [0.05MCi]/kg of [18F]CSF-23 in a single dose.

Outcome Measures

Primary Outcome Measures

1. Complete PET imaging [90mins from time of injection]

   To assess the diagnostic value of [18F]CSF-23 brain imaging for CSF1R expression in Alzheimer's disease.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huashan Hospital	Shanghai		China	200040

Sponsors and Collaborators

• Huashan Hospital

Investigators

• Principal Investigator: Fang Xie, PhD, Huashan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: YiHui Guan, Professor, Huashan Hospital
• ClinicalTrials.gov Identifier: NCT06148233
• Other Study ID Numbers: KY2023-780
• First Posted: Nov 28, 2023
• Last Update Posted: Nov 28, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease; Neurodegenerative Diseases

Study Results

No Results Posted as of Nov 28, 2023