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

The main objective of this study is to establish a standardized method for [18F] - FD17 PET imaging in α-synucleinopathy patients, and to analyze its physiological distribution in healthy individuals as well as its pathological distribution in α-synucleinopathy patients, including Parkinson's disease (PD), multiple system atrophy (MSA), and idiopathic rapid-eye-movement sleep behavior disorder (iRBD). Specifically, [18F] - FD17 PET imaging focuses on evaluating the deposition of α-synuclein and exploring the diagnostic value of [18F] - FD17 PET in PD, MSA, and iRBD patients. In addition, for PD, MSA and RBD patients, dopamine transporter(DAT)-PET imaging was performed to evaluate the distribution and density of DAT in brain. The study aims not only to clarify the specific binding mode of the imaging agent in different α-synucleinopathies, but also to evaluate its efficacy and potential application prospects in early diagnosis , providing new methods for the diagnosis and treatment of neurodegenerative diseases. This study is expected to contribute to early pathological detection and accurate diagnosis in clinical practice.

Study Overview

• Status: Completed
• Conditions: Multiple System Atrophy; Parkinson's Disease (PD); PET; Rapid Eye Movement Sleep Behavior Disorder; α-synucleinopathy
• Intervention / Treatment: Other: PET

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

10 PD subjects ,10 MSA subjects, 10 RBD subjects ,and 5 healthy control subjects

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PD group	Other: PET; [18F] - FD17 PET imaging
MSA group	Other: PET; [18F] - FD17 PET imaging
RBD group	Other: PET; [18F] - FD17 PET imaging
HC group	Other: PET; [18F] - FD17 PET imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
electrocardiogram	Heart rate, atrial rate, ventricular rate, P-R interval, QRS axis, QRS duration, QRS potential, and all other electrocardiographic indicators will be collected by 12-lead electrocardiogram. These outcomes will be used to figure out whether the subjects have a potential heart disease and whether [18F] - FD17 PET/MRI will do harm to subjects.	2 weeks ahead of and after [18F] - FD17 PET/MRI
routine blood test	10ml peripheral venous blood will be collected and to measure red blood cell cell count and percentage, hemoglobin content, white blood cell count and percentage, platelet count, and all other indicators in routine blood test. These outcomes will be used to figure out whether the subjects have a potential disease and whether [18F] - FD17 PET/MRI will do harm to subjects.	2 weeks ahead of and after [18F] - FD17 PET/MRI
routine urine test	20ml urine will be collected for routine urine test. Indicators including red blood cell and white blood cell count under a microscope, urine specific gravity, urine PH, urinary protein, glucose in urine and all others will be measured. These outcomes will be used to figure out whether the subjects have a potential disease and whether [18F] - FD17 PET/MRI will do harm to subjects.	2 weeks ahead of and after [18F] - FD17 PET/MRI
liver renal function test	10ml peripheral venous blood will be collected and to measure alanine aminotransferase(ALT), aspartate aminotransferase(AST), alkaline phosphatase(ALP), Gamma-glutamyltransferase(GGT), creatinine, urea nitrogen, uric acid and all other liver renal function test indicators in serum. These outcomes will be used to figure out whether the subjects have potential hepatorenal dysfunction and whether [18F] - FD17 PET/MRI will do harm to subjects.	2 weeks ahead of and after [18F] - FD17 PET/MRI

Secondary Outcome Measures

Outcome Measure	Time Frame
[18F] - FD17 PET imaging results	Baseline

Other Outcome Measures

Outcome Measure	Time Frame
DAT(dopamine transporter) PET imaging results	Baseline

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: National Natural Science Foundation of China

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2024
• Primary Completion (Actual): December 25, 2025
• Study Completion (Actual): December 25, 2025

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurodegenerative Diseases; Sleep Wake Disorders; Movement Disorders; Basal Ganglia Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Parasomnias; REM Sleep Parasomnias; Multiple System Atrophy; REM Sleep Behavior Disorder
• Other Study ID Numbers: [18F]-FD17 PET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No