Tauopathies
Conditions
Interventions
Gold Standard:Clinical diagnostic criteria for Alzheimer's disease (NIA-AA 2011) and clinical diagnostic criteria for Pediatric spastic syndrome (MDS 2017).
Index test:18F-RAC-1997 Semi-quantitative analysis and visual interpretation
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: Clinical trial participants must meet all of the following criteria. Common inclusion criteria for all study participants: 1. Written informed consent signed by the participant or their legal guardian. 2. Participants may be accompanied by a caregiver if necessary. 3. Patients who can provide informed consent (signed by the individual if capable of giving informed consent; signed by the participant, family member, or legal representative if not capable of giving informed consent) prior to any evaluation, in accordance with the guidelines of the Clinical Research Ethics Committee. 4. Female participants must have medical records proving they have undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for more than one year; if still capable of conceiving, they must use abstinence contraception during this study. 5. Male participants must use abstinence contraception during this study. Male participants may not donate sperm during this study. 6. Willingness and ability to cooperate with all aspects of this study. 7. Complete blood count: White blood cell count (WBC) 4–10 × 10^9/L; Platelet count (PLT) 100–300 × 10^9/L; Hemoglobin (HB) 120–160 g/L. 8. Renal function: Serum creatinine less than or equal to the upper limit of normal. 9. Liver function: Bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of normal. 10. Electrocardiogram: No significant abnormalities. 11. Age between 45 and 70 years; gender not limited. 12. Possess basic understanding and communication skills to complete the clinical scale assessment. Inclusion criteria for AD patients: 1. Patients meet the clinical diagnostic criteria for AD (NIA-AA 2011). 2. Brain amyloid PET/cerebrospinal fluid tests support the diagnosis of AD, and there is no evidence of other neurological diseases. 3. Medications used to improve clinical symptoms of Alzheimer's disease (AD) must be maintained at a stable dose for at least 30 days before initiating this study. Inclusion criteria for PSP patients: 1. Patients meet the clinical diagnostic criteria for PSP (MDS 2017). 2. Patients can still walk independently with the aid of external objects at the first visit (Hoehn-Yahr scale (H&Y) grade <=4). 3. No evidence of other neurological disorders. 4. Medications used to improve clinical symptoms of PSP must be maintained at a stable dose for at least 30 days before initiating this study. Non-disease controls: 1. No subjective complaints or objective evidence of neurological disorders, and no relevant family history. 2. Confirmed by the investigator as having no neurological disorders, major chronic diseases, malignancies, or acute infectious diseases.
Exclusion criteria
Exclusion criteria: Applicable to all study participants: 1. Those with severe other neurological disorders, or serious gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, respiratory, immunodeficiency, or other serious diseases. 2. Those who have received ionizing radiation outside the scope of this study within the past year for other clinical, medical, or scientific research purposes, resulting in an annual radiation exposure exceeding 50 mSv. 3. Those with a history of drug abuse or alcoholism. 4. Those who are pregnant or breastfeeding. 5. Those with poor venous access who cannot tolerate repeated venipuncture. 6. Those who have received treatment with an experimental drug or device (of uncertain efficacy or safety) within the past month. 7. Those who may be allergic to any component of the 18F-RAC-1997 injection solution. 8. Those with any condition that the study principal investigator deems potentially harmful or harmful in any aspect of this study. AD patients: 1. Those who have received Abeta treatment within the past 3 months. 2. Those who have received tau treatment within the past 3 months. PSP Patients: 1. Received tau-targeting medication within the past 3 months. Study Participant Withdrawal Criteria: Applicable to all study participants: 1. Lost to follow-up. 2. Incorrectly enrolled study participants. 3. No evaluable records after medication administration. 4. Seriously violated the study protocol during the trial. 5. Used concomitant medications or treatments prohibited by the protocol. 6. Study participants may voluntarily withdraw from the study at any time before and during the trial. 7. The investigator determines before and during the trial that continuing the trial may be detrimental to the study participant, including the following: abnormal laboratory test results (including complete blood count, electrolytes, liver and kidney function) and electrocardiogram results before or after the trial. 8. Abnormal changes in vital signs 10 minutes before, 10 minutes after, and 30 minutes after injection, and during observation after the scan. 9. Occurrence of adverse events (AEs) and serious adverse events (SAEs) during the study, including but not limited to: changes in vital signs during periodic monitoring from the start of the clinical study to subsequent clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized uptake value ratio;Accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual interpretation;Sensitivity;Specificity; | — |
Countries
China
Contacts
Public ContactYihui Guan
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed