Brain imaging for Alzheimer's disease using a new PET probe

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

This study is testing a new brain imaging technique to see if it can help detect a specific protein related to Alzheimer's disease in both patients and healthy individuals.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 60 Years to 80 Years
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai)
• Trial ID: NCT06148233 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the diagnostic potential of the PET probe [18F]CSF-23 for assessing CSF1R expression in the brains of individuals with Alzheimer's disease. By utilizing positron emission tomography (PET) imaging, the study seeks to determine the role of CSF1R in Alzheimer's and to assess the safety and effectiveness of this imaging technique. Participants will include cognitively normal individuals as controls to establish baseline measurements. The study will focus on the correlation between CSF1R expression and Alzheimer's pathology.

Who should consider this trial

Good fit: Ideal candidates for this study are cognitively normal individuals aged 60 to 80 with no neurological or major chronic diseases.

Not a fit: Patients with existing neurological diseases, major chronic illnesses, or those who do not meet the cognitive criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the diagnostic accuracy for Alzheimer's disease, leading to earlier and more effective interventions.

How similar studies have performed: While the use of PET imaging in Alzheimer's research is established, the specific application of the [18F]CSF-23 probe represents a novel approach that has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Huashan Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Fang Xie, PhD — Huashan Hospital
• Study coordinator: Yihui Guan, MD

Conditions Positron Emission Tomography; Alzheimer Disease; Neurodegenerative Diseases