Multiple System Atrophy - Cerebellar Subtype (MSA-C)NCT06890377
Targeted Α-synuclein PET Imaging in the Diagnosis of Multiple System Atrophy
An observational study of Multiple System Atrophy - Cerebellar Subtype (MSA-C) and Multiple System Atrophy - Parkinsonian Subtype (MSA-P), run by Min Zhao,MD at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple System Atrophy - Cerebellar Subtype (MSA-C), Multiple System Atrophy - Parkinsonian Subtype (MSA-P)
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2024to 31 Mar 2026
- 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People who came to Third Xiangya Hospital of Central South University for consultation or online questionnaire recruitment
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Xiangya Hospital of Central South University
Hunan, Changsha, 410000
Zhao M, 3687373641, mzhao1981@csu.edu.cn
About this study
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.
- Conditions
- Multiple System Atrophy - Cerebellar Subtype (MSA-C), Multiple System Atrophy - Parkinsonian Subtype (MSA-P)
- Keywords
- Multiple System Atrophy, PETCT, α-synuclein
- Medical subject headings
- Multiple System Atrophy, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Standard uptake value ratio(SUVR)
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (6)
UMSARS
Unified Multiple System Atrophy Rating Scale
Measured: From enrollment to the end of treatment at 4 weeks
H-Y stage
Measured: From enrollment to the end of treatment at 4 weeks
SCOPA-AUT
Parkinson's Disease Autonomic Symptoms Scale
Measured: From enrollment to the end of treatment at 4 weeks
Wexner score
Wexner Continence Grading Scale
Measured: From enrollment to the end of treatment at 4 weeks
Frontal Assessment Battery
Measured: From enrollment to the end of treatment at 4 weeks
MoCA score
Montreal Cognitive Assessment
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start14 Sep 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System Atrophy - Cerebellar Subtype (MSA-C)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Zhao,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Zhao,MD, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890377
- Sponsor's protocol ID
- Rapid24408
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Α-synuclein PET Imaging in the Diagnosis of Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT06890377
- Acronym / sponsor ID
- Rapid24408
- Conditions
- Multiple System Atrophy - Cerebellar Subtype (MSA-C), Multiple System Atrophy - Parkinsonian Subtype (MSA-P)
- Keywords
- Multiple System Atrophy, PETCT, α-synuclein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Min Zhao,MDUniversity, hospital or other
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 24 Mar 2025 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People who came to Third Xiangya Hospital of Central South University for consultation or online questionnaire recruitment
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Standard uptake value ratio(SUVR)
Time frame: From enrollment to the end of treatment at 4 weeks
6 secondary outcomes
UMSARS
Time frame: 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
SCOPA-AUT
Time frame: From enrollment to the end of treatment at 4 weeks
Wexner score
Time frame: 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
MoCA score
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
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 Multiple System Atrophy - Cerebellar Subtype (MSA-C) and Multiple System Atrophy - Parkinsonian Subtype (MSA-P), run by Min Zhao,MD 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Mar 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He RQ 何 (0086-18622148869, hrq1234562001@163.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard uptake value ratio(SUVR) (time frame: From enrollment to the end of treatment at 4 weeks). 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 24 Mar 2025.