Imaging α-synuclein in patients with neurodegenerative disorders
[18F] - FD17 PET Imaging of α-synuclein: A Clinical Study in α-synucleinopathy Patients
This study is testing a new imaging method to see if it can help identify the buildup of a protein linked to Parkinson's disease and other related disorders in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06738862 on ClinicalTrials.gov |
What this trial studies
This study aims to standardize the use of [18F] - FD17 PET imaging to evaluate α-synuclein deposition in patients with α-synucleinopathies, including Parkinson's disease, multiple system atrophy, and idiopathic rapid-eye-movement sleep behavior disorder. It will analyze the physiological distribution of the imaging agent in healthy individuals and its pathological distribution in affected patients. Additionally, dopamine transporter PET imaging will be performed to assess the distribution and density of dopamine transporters in the brain. The goal is to clarify the binding mode of the imaging agent and evaluate its diagnostic potential for early detection of these conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Parkinson's disease, multiple system atrophy, or idiopathic rapid-eye-movement sleep behavior disorder, as well as healthy individuals without neurological disorders.
Not a fit: Patients with significant neurological disorders, major chronic diseases, or acute infectious diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and treatment strategies for patients with α-synucleinopathies.
How similar studies have performed: Other studies have shown promise in using PET imaging for similar neurodegenerative conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai
- Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: JUN LIU, Professor
- Email: lj11128@rjh.com.cn
- Phone: 15221303819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.