α-synucleinopathyNCT06738862
[18F] - FD17 PET Imaging of α-synuclein: A Clinical Study in α-synucleinopathy Patients
An observational study of α-synucleinopathy and Parkinson's Disease (PD), run by Ruijin Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- α-synucleinopathy, Parkinson's Disease (PD), Multiple System Atrophy
- What is being tested?
- PET
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2024to 25 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 PD subjects ,10 MSA subjects, 10 RBD subjects ,and 5 healthy control subjects
Who may be able to join
- 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)
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
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.
- Conditions
- α-synucleinopathy, Parkinson's Disease (PD), Multiple System Atrophy, Rapid Eye Movement Sleep Behavior Disorder, PET
- Being tested
- PET
- Medical subject headings
- Multiple System Atrophy, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETOther
[18F] - FD17 PET imaging
| Study group | Role | What they receive |
|---|---|---|
| PD group | Not described Receives: Other: PET | |
| MSA group | Not described Receives: Other: PET | |
| RBD group | Not described Receives: Other: PET | |
| HC group | Not described Receives: Other: PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks ahead of and after [18F] - FD17 PET/MRI
Secondary outcomes (1)
[18F] - FD17 PET imaging results
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start14 Dec 2024
- Primary completion25 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for α-synucleinopathyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738862
- Sponsor's protocol ID
- [18F]-FD17 PET
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F] - FD17 PET Imaging of α-synuclein: A Clinical Study in α-synucleinopathy Patients
- ClinicalTrials.gov ID
- NCT06738862
- Acronym / sponsor ID
- [18F]-FD17 PET
- Conditions
- α-synucleinopathy, Parkinson's Disease (PD), Multiple System Atrophy, Rapid Eye Movement Sleep Behavior Disorder, PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 14 Dec 2024 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PD group | – | Other: PET |
| MSA group | – | Other: PET |
| RBD group | – | Other: PET |
| HC group | – | Other: PET |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 PD subjects ,10 MSA subjects, 10 RBD subjects ,and 5 healthy control subjects
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET[18F] - FD17 PET imaging | Other | HC group, MSA group, PD group, RBD group |
Primary outcome
electrocardiogram
Time frame: 2 weeks ahead of and after [18F] - FD17 PET/MRI
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.
routine blood test
Time frame: 2 weeks ahead of and after [18F] - FD17 PET/MRI
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.
routine urine test
Time frame: 2 weeks ahead of and after [18F] - FD17 PET/MRI
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.
liver renal function test
Time frame: 2 weeks ahead of and after [18F] - FD17 PET/MRI
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.
1 secondary outcome
[18F] - FD17 PET imaging results
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for α-synucleinopathy
RecruitingEarly Phase 1
[18F]ACI-15916 PET in α-synucleinopathies
Parkinson's Disease (PD), Multiple System Atrophy (MSA)
RecruitingPhase 2
Prevent Cognitive Decline in GBA-associated Parkinson's Disease
Parkinson's Disease
RecruitingPhase 1
MK-0947 PN-002: An Open-label Study to Evaluate Brain α-synuclein Deposition Using Positron Emission Tomography (PET) and [¹⁸F]MK-0947 in Participants With Parkinson's Disease (PD)
Parkinsons Disease (PD), Healthy Elderly Volunteers
RecruitingObservational study
Alpha-Synuclein PET/CT in Various α-Syn-Related Disease
Alpha Synuclein Pathology, Alpha-Synuclein
Not yet recruitingPhase 1
A Prospective Exploratory Study of the Safety and Preliminary Efficacy of the α-Syn H21 Monoclonal Antibody in Patients With Multiple System Atrophy
Multiple System Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of α-synucleinopathy and Parkinson's Disease (PD), run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
electrocardiogram (time frame: 2 weeks ahead of and after [18F] - FD17 PET/MRI). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.