[18F] - FD17 PET Imaging of α-synuclein: A Clinical Study in α-synucleinopathy Patients

Launched by RUIJIN HOSPITAL · Dec 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special type of imaging called \[18F\] - FD17 PET imaging, which helps doctors see the buildup of a protein called α-synuclein in the brains of people with certain conditions, such as Parkinson's disease, multiple system atrophy, and rapid eye movement sleep behavior disorder. The main goal is to create a standardized way to use this imaging technique, helping to improve the early diagnosis and treatment of these neurodegenerative diseases. By comparing healthy individuals with those diagnosed with these conditions, researchers hope to better understand how this imaging works and its potential benefits for patients.

To participate in this study, individuals must meet certain criteria. For healthy participants, they should have normal cognitive function and no serious health issues. Patients with Parkinson's disease, multiple system atrophy, or rapid eye movement sleep behavior disorder must have a clinical diagnosis of their condition. Participants need to be able to sign an informed consent form and will be required to cooperate with the study procedures. The trial is not yet recruiting, but it aims to provide valuable insights into diagnosing and treating these challenging neurological conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1: Normal cognitive function, CDR score=0（for healthy subjects）
• • 2: Without neurological disorders, major chronic diseases, malignant tumors, or acute infectious diseases (for healthy subjects）
• • 3: Without the family history of neurological disorders related to motor or cognitive impairments(for healthy subjects）
• • 4: Clinical diagnosis of idiopathic PD (for PD patients)
• • 5: Clinical diagnosis of MSA (for MSA patients)
• • 6: Clinical diagnosis of idiopathic RBD (for RBD patients)
• • 7: An informed consent form signed in writing by the subject or their legal guardian or caregiver.
• • 8: Must be abled to be accompanied by nursing staff
• • 9: Must be able to understand and sign a informed consent form before any evaluation and examination
• • 10: Must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause for more than one year.(for female subjects)
• • 11: Must adopt isolation contraception measures within 3 months after the start of this study.(for female subjects)
• • 12: Willing and capable to cooperate with all projects of this study.
• Exclusion Criteria:
• • 1: Other severe neurological disorders. Gastrointestinal, cardiovascular, liver, kidney, hematological, tumor, endocrine, respiratory, immunodeficiency, and other serious diseases.
• • 2: Received ionizing radiation outside the scope of this experiment, resulting in an annual radiation exposure dose exceeding 50 mSv in the past year,
• • 3: History of drug abuse or alcoholism
• • 4: Pregnant or lactating women
• • 5: Poor venous conditions, unable to tolerate repeated venipuncture
• • 6: Received experimental drug or device treatment with unclear efficacy or safety in last 1 month.
• • 7: Any situation that the investigators believe may cause harm or potential harm in any aspect related to this study