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RecruitingNCT06148233Updated Nov 28, 2023

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

An interventional study of [18F]CSF-23 in Positron Emission Tomography, Alzheimer Disease and Neurodegenerative Diseases, sponsored by Huashan Hospital. Recruiting at 1 site in China. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by Huashan Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
60 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Positron Emission Tomography
  • Alzheimer Disease
  • Neurodegenerative Diseases
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    patients with Alzheimer's Disease

    AD subjects recruited from geriatric wards or memory clinics.

    Radiation: [18F]CSF-23

  • Experimental
    Cognitively normal control group

    Cognitively normal subjects recruited from the community

    Radiation: [18F]CSF-23

Interventions

  • Radiation[18F]CSF-23

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

06

What researchers measure

Primary outcomes

  1. Complete PET imaging

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

    Time frame: 90mins from time of injection

07

Study locations

1 of 1 sites recruiting
  • Huashan Hospital
    Shanghai, 200040, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06148233
Lead sponsor
Huashan Hospital
Responsible party
YiHui Guan (Professor, Huashan Hospital) — Principal investigator
First posted
Nov 28, 2023
Start date
Sep 15, 2023
Primary completion
Jun 16, 2024 (estimated)
Completion
Sep 14, 2024 (estimated)
Last update
Nov 28, 2023

Study contacts

Yihui Guan, MD
Contact
guanyihui@hotmail.com
13764308300 ext. +86
Fang Xie, PhD
principal investigator · Huashan Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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