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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurodegenerative Diseases; Alzheimer Disease; Positron Emission Tomography
• Intervention / Treatment: Radiation: [18F]CSF-23

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yihui Guan, MD; Phone Number: +86 13764308300; Email: guanyihui@hotmail.com

Study Locations

• China
  • Shanghai, China, 200040
    • Recruiting
    • Huashan Hospital
    • Contact: Yihui Guan, MD; Phone Number: +86 13764308300; Email: guanyihui@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Investigators: Principal Investigator: Fang Xie, PhD, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): June 16, 2024
• Study Completion (Estimated): September 14, 2024

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia; Tauopathies; Alzheimer Disease; Neurodegenerative Diseases
• Other Study ID Numbers: KY2023-780

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No