CSF1R PET Probe [18F]CSF-23 in Alzheimer's Disease Brain Imaging
NCT ID: NCT06148233
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-09-15
2024-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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patients with Alzheimer's Disease
AD subjects recruited from geriatric wards or memory clinics.
[18F]CSF-23
Intravenous injection of 1.8 MBq \[0.05MCi\]/kg of \[18F\]CSF-23 in a single dose.
Cognitively normal control group
Cognitively normal subjects recruited from the community
[18F]CSF-23
Intravenous injection of 1.8 MBq \[0.05MCi\]/kg of \[18F\]CSF-23 in a single dose.
Interventions
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[18F]CSF-23
Intravenous injection of 1.8 MBq \[0.05MCi\]/kg of \[18F\]CSF-23 in a single dose.
Eligibility Criteria
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Inclusion Criteria
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
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.
60 Years
80 Years
ALL
Yes
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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YiHui Guan
Professor
Principal Investigators
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Fang Xie, PhD
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Locations
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Huashan Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY2023-780
Identifier Type: -
Identifier Source: org_study_id