Multiple System AtrophyNCT06221644
Synapse Alterations in MSA Patients
An observational study of Multiple System Atrophy, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Synaptic loss has been implicated in various neurodegenerative conditions, yet its understanding in multiple system atrophy (MSA) remains limited. The aim of this study was to examine spatial synaptic density alterations in MSA patients and evaluate the potential of [18F]SynVesT-1 PET as an imaging biomarker for MSA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- [18F]SynVesT-1 PET/CT
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 25 Nov 2022
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: 60 patients diagnosed with MSA were recruited. The patient cohort consisted of 30 MSA-C and 30 MSA-P cases, diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists. Additionally, 30 gender and age-matched HCs were included.
Who may be able to join
- The MSA patient were diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists.
Who cannot join
- encompassed MRI contraindications, a history of epilepsy, stroke, or brain surgery, intracranial organic lesions unrelated to MSA, usage of levetiracetam or brivaracetam, and a history of alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Synaptic loss has been implicated in various neurodegenerative conditions, yet its understanding in multiple system atrophy (MSA) remains limited.
The aim of this study was to examine spatial synaptic density alterations in MSA patients and evaluate the potential of [18F]SynVesT-1 PET as an imaging biomarker for MSA in both diagnosis and monitoring disease severity.
Read the detailed description
60 MSA patients (30 MSA-P subtype and 30 MSA-C subtype) and 30 age-matched healthy controls (HCs) underwent [18F]SynVesT-1 PET/CT for synaptic density assessment. Visual, voxel, and volumetric region-of-interest (VOI) analyses were employed to elucidate synaptic density patterns in the MSA brain and establish visual diagnostic criteria. VOI-based computer-assisted analyses were utilized to develop diagnostic models for MSA.
- Conditions
- Multiple System Atrophy
- Being tested
- [18F]SynVesT-1 PET/CT
- Keywords
- synaptic density; PET; SV2A
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]SynVesT-1 PET/CTDiagnostic test
60 MSA patients (30 MSA-P subtype and 30 MSA-C subtype) and 30 age-matched healthy controls (HCs) underwent [18F]SynVesT-1 PET/CT for synaptic density assessment
| Study group | Role | What they receive |
|---|---|---|
| MSA patients group | The patient cohort consisted of 30 MSA-C and 30 MSA-P cases, diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists Receives: Diagnostic Test: [18F]SynVesT-1 PET/CT | |
| healthy controls (HCs) group | 30 gender and age-matched HCs were included Receives: Diagnostic Test: [18F]SynVesT-1 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial synaptic density alterations in MSA patients
To examine spatial synaptic density alterations in MSA patients
Measured: 10 months
[18F]SynVesT-1 PET as an imaging biomarker for MSA
evaluate the potential of [18F]SynVesT-1 PET as an imaging biomarker for MSA
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Apr 2022
- Primary completion30 Oct 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuo Hu, Study chair, Shuo Hu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221644
- Sponsor's protocol ID
- 20240113
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- 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 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synapse Alterations in MSA Patients
- ClinicalTrials.gov ID
- NCT06221644
- Acronym / sponsor ID
- 20240113
- Conditions
- Multiple System Atrophy
- Keywords
- synaptic density; PET; SV2A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 24 Jan 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.
Synaptic loss has been implicated in various neurodegenerative conditions, yet its understanding in multiple system atrophy (MSA) remains limited.
The aim of this study was to examine spatial synaptic density alterations in MSA patients and evaluate the potential of [18F]SynVesT-1 PET as an imaging biomarker for MSA in both diagnosis and monitoring disease severity.
Detailed description
60 MSA patients (30 MSA-P subtype and 30 MSA-C subtype) and 30 age-matched healthy controls (HCs) underwent [18F]SynVesT-1 PET/CT for synaptic density assessment. Visual, voxel, and volumetric region-of-interest (VOI) analyses were employed to elucidate synaptic density patterns in the MSA brain and establish visual diagnostic criteria. VOI-based computer-assisted analyses were utilized to develop diagnostic models for MSA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSA patients group | – | Diagnostic Test: [18F]SynVesT-1 PET/CTThe patient cohort consisted of 30 MSA-C and 30 MSA-P cases, diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists |
| healthy controls (HCs) group | – | Diagnostic Test: [18F]SynVesT-1 PET/CT30 gender and age-matched HCs were included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 60 patients diagnosed with MSA were recruited. The patient cohort consisted of 30 MSA-C and 30 MSA-P cases, diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists. Additionally, 30 gender and age-matched HCs were included.
Key inclusion criteria (1 listed)
- The MSA patient were diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists.
Key exclusion criteria (1 listed)
- encompassed MRI contraindications, a history of epilepsy, stroke, or brain surgery, intracranial organic lesions unrelated to MSA, usage of levetiracetam or brivaracetam, and a 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]SynVesT-1 PET/CT60 MSA patients (30 MSA-P subtype and 30 MSA-C subtype) and 30 age-matched healthy controls (HCs) underwent [18F]SynVesT-1 PET/CT for synaptic density assessment | Diagnostic test | MSA patients group, healthy controls (HCs) group |
Primary outcome
Spatial synaptic density alterations in MSA patients
Time frame: 10 months
To examine spatial synaptic density alterations in MSA patients
[18F]SynVesT-1 PET as an imaging biomarker for MSA
Time frame: 10 months
evaluate the potential of [18F]SynVesT-1 PET as an imaging biomarker for MSA
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 25 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Shuo Hu study chair
Shuo Hu
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, run by Xiangya Hospital of Central South University 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 1 inclusion and 1 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 25 Jan 2024. 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?
Spatial synaptic density alterations in MSA patients (time frame: 10 months). The study lists 2 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 25 Jan 2024.