- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06221644
Synapse Alterations in MSA Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Hunan
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Changsha, Hunan, China, 410008
- Jian Li
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
The MSA patient were diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists.
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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
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healthy controls (HCs) group
30 gender and age-matched HCs were included
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spatial synaptic density alterations in MSA patients
Time Frame: 10 months
|
To examine spatial synaptic density alterations in MSA patients
|
10 months
|
[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
|
10 months
|
Collaborators and Investigators
Investigators
- Study Chair: Shuo Hu, Shuo Hu
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Hypotension
- Multiple System Atrophy
- Shy-Drager Syndrome
Other Study ID Numbers
- 20240113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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