Synapse Alterations in MSA Patients

Multiple System Atrophy Clinical Trial

Official title:

Synapse Alterations in MSA Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06221644
• Other study ID #: 20240113
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: November 25, 2022

Study information

• Verified date: January 2024
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 in both diagnosis and monitoring disease severity.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 25, 2022
• Est. primary completion date: October 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple System Atrophy
• Shy-Drager Syndrome

Intervention

Diagnostic Test:
• [18F]SynVesT-1 PET/CT
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

Locations

Country	Name	City	State
China	Jian Li	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spatial synaptic density alterations in MSA patients	To examine spatial synaptic density alterations in MSA patients	10 months
Primary	[18F]SynVesT-1 PET as an imaging biomarker for MSA	evaluate the potential of [18F]SynVesT-1 PET as an imaging biomarker for MSA	10 months