Synapse Alterations in MSA Patients

Completed

• Conditions: Multiple System Atrophy
• Interventions: Diagnostic Test: [18F]SynVesT-1 PET/CT

• Registration Number: NCT06221644
• Lead Sponsor: Xiangya Hospital of Central South University

Brief 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.

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 Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-10-30
• Study Completion: 2022-11-25
• Status Verified: 2024-01
• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-24
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy controls (HCs) group	[18F]SynVesT-1 PET/CT	30 gender and age-matched HCs were included
MSA patients group	[18F]SynVesT-1 PET/CT	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

Primary Outcome Measures

Name	Time	Method
[18F]SynVesT-1 PET as an imaging biomarker for MSA	10 months	evaluate the potential of \[18F\]SynVesT-1 PET as an imaging biomarker for MSA
Spatial synaptic density alterations in MSA patients	10 months	To examine spatial synaptic density alterations in MSA patients

Trial Locations

Locations (1)

Jian Li; 🇨🇳 Changsha, Hunan, China