Targeted Α-synuclein PET Imaging in the Diagnosis of Multiple System Atrophy

March 20, 2025 updated by: Min Zhao,MD
The aim of this study was to apply the targeted α-synuclein PET study technique to investigate the pathological load and spatial distribution characteristics of α-syn in MSA patients, and to assess its value as a biomarker for diagnostic typing, disease severity, and prognosis in MSA.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Changsha
      • Hunan, Changsha, China, 410000
        • Recruiting
        • Third Xiangya Hospital of Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

People who came to Third Xiangya Hospital of Central South University for consultation or online questionnaire recruitment

Description

Inclusion Criteria:

  • Age> 35 years old, gender is not limited;
  • Clinically confirmed MSA and clinically probable MSA according to the 2022 MDS MSA diagnostic criteria;
  • all patients had been ruled out of polyQ disease by genetic testing;
  • Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

  • pregnancy or breastfeeding;
  • contraindications to MRI examination or inability to cooperate in completing neuroimaging examination;
  • previous history of other neurological disorders or presence of other organic intracranial lesions on neuroimaging that cannot be interpreted by MSA, such as epilepsy, trauma, tumors, or high-grade cerebral white matter degeneration (Fazekas grade 2 and above);
  • History of alcohol or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MSA-C group
Clinically confirmed MSA and clinically probable MSA according to the 2022 MDS MSA diagnostic criteria，and have symptoms of MSA-C type (with cerebellar ataxia as the main manifestation) mainly include progressive cerebellar ataxia and autonomic dysfunction.
MSA-P group
Clinically confirmed MSA and clinically probable MSA according to the 2022 MDS MSA diagnostic criteria，and have symptoms of MSA-P (multiple system atrophy-P type) mainly include autonomic dysfunction, Parkinson's syndrome and cerebellar ataxia.
healthy control group
The healthy person who age, gender and other basic conditions matched with the MSA cohort population，and voluntarily participate in this study and sign the informed consent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Standard uptake value ratio(SUVR)
Time Frame: From enrollment to the end of treatment at 4 weeks
From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UMSARS
Time Frame: From enrollment to the end of treatment at 4 weeks
Unified Multiple System Atrophy Rating Scale
From enrollment to the end of treatment at 4 weeks
H-Y stage
Time Frame: From enrollment to the end of treatment at 4 weeks
From enrollment to the end of treatment at 4 weeks
SCOPA-AUT
Time Frame: From enrollment to the end of treatment at 4 weeks
Parkinson's Disease Autonomic Symptoms Scale
From enrollment to the end of treatment at 4 weeks
Wexner score
Time Frame: From enrollment to the end of treatment at 4 weeks
Wexner Continence Grading Scale
From enrollment to the end of treatment at 4 weeks
Frontal Assessment Battery
Time Frame: From enrollment to the end of treatment at 4 weeks
From enrollment to the end of treatment at 4 weeks
MoCA score
Time Frame: From enrollment to the end of treatment at 4 weeks
Montreal Cognitive Assessment
From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Min Zhao,MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rapid24408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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