Last updated: November 19, 2023
Sponsor: Huashan Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Neurologic Disorders
Multiple Sclerosis
Treatment
[18F]CSF-23
Clinical Study ID
NCT06148233
KY2023-780
Ages 60-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Non-diseased controls:
- Between 60 and 80 years of age; gender is not limited.
- Cognitively normal as determined by the investigator through testing, with anMMSE score greater than 25 and no cognitive domain impairment. They had anegative Aβ image.
- No neurological diseases, major chronic diseases, malignant tumors, or acuteinfectious diseases, as determined by the investigator.
- Written informed consent must be signed by the subject or his/her legal guardianor caregiver.
- Blood routine: white blood cell count (WBC) 4
10×109/L; platelet (PLT) 100300×109/L; hemoglobin (HB) 120~160 g/L; renal function: serum creatinine lessthan 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 thenormal range; Electrocardiogram: no significant abnormalities. - No neurological diseases, major chronic diseases, malignant tumors, or acuteinfectious diseases, as confirmed by the investigator; no family history ofneurodegenerative movement disorders, and no family history of neurologicaldisorders 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 havepositive Aβ images.
- Brain MRI supported the diagnosis of AD and there was no evidence of otherneurological diseases.
- No neurological diseases, major chronic diseases, malignant tumors or acute infectiousdiseases, etc., as confirmed by the investigator.
- Written informed consent must be signed by the subject or his/her legal guardian orcaregiver.
- Blood routine: white blood cell count (WBC) 4
10×109/L; platelet (PLT) 100300×109/L;hemoglobin (HB) 120~160 g/L; renal function: serum creatinine less than or equal tothe 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 significantabnormalities. - No neurological diseases, major chronic diseases, malignant tumors, or acuteinfectious diseases, as confirmed by the investigator; no family history ofneurodegenerative movement disorders, and no family history of neurological disordersrelated to movement disorders.
- Willingness and ability to cooperate with all programs of this study.
Exclusion
Exclusion Criteria:
- 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 thisclinical study, which has resulted in radiation exposure in excess of aneffective dose of 50 mSv.
- Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upperlimit of the normal range.
- History of serious surgery in the last month.
- Participation in other clinical trials during the same period.
Study Design
Total Participants: 40
Treatment Group(s): 1
Primary Treatment: [18F]CSF-23
Phase:
Study Start date:
September 15, 2023
Estimated Completion Date:
September 14, 2024
Connect with a study center
Huashan Hospital
Shanghai, 200040
ChinaActive - Recruiting

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