NCT06221644

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

January 15, 2024

Last Update Submit

January 24, 2024

Conditions

Keywords

synaptic density; PET; SV2A

Outcome Measures

Primary Outcomes (2)

  • Spatial synaptic density alterations in MSA patients

    To examine spatial synaptic density alterations in MSA patients

    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

    10 months

Study Arms (2)

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

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

healthy controls (HCs) group

30 gender and age-matched HCs were included

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

Interventions

[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

MSA patients grouphealthy controls (HCs) group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • The MSA patient were diagnosed according to the 2008 Second Consensus Criteria and confirmed by two experienced neurologists.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jian Li

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Multiple System Atrophy

Condition Hierarchy (Ancestors)

Primary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Shuo Hu

    Shuo Hu

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2024

First Posted

January 24, 2024

Study Start

April 1, 2022

Primary Completion

October 30, 2022

Study Completion

November 25, 2022

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations