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

NCT06148233 | Unknown DMC

• 1 other identifier: KY2023-780
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Positron Emission Tomography; Alzheimer Disease; Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

patients with Alzheimer's Disease

EXPERIMENTAL

AD subjects recruited from geriatric wards or memory clinics.

Radiation: [18F]CSF-23

Cognitively normal control group

EXPERIMENTAL

Cognitively normal subjects recruited from the community

Radiation: [18F]CSF-23

Interventions

[18F]CSF-23 RADIATION

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

Cognitively normal control group; patients with Alzheimer's Disease

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders

Study Officials

• Fang Xie, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihui Guan, MD

CONTACT

13764308300; guanyihui@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 28, 2023
• Study Start: September 15, 2023
• Primary Completion: June 16, 2024
• Study Completion: September 14, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

CN (1)