Synapse Alterations in MSA Patients

NCT ID: NCT06221644

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-11-25

Brief Summary

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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

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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. 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

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Multiple System Atrophy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

[18F]SynVesT-1 PET/CT

Intervention Type DIAGNOSTIC_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

healthy controls (HCs) group

30 gender and age-matched HCs were included

[18F]SynVesT-1 PET/CT

Intervention Type DIAGNOSTIC_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

Interventions

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[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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shuo Hu

Role: STUDY_CHAIR

Shuo Hu

Locations

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Jian Li

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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20240113

Identifier Type: -

Identifier Source: org_study_id

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