NCT06490926

Brief Summary

At present, the diagnosis of Parkinsons disease(PD) mainly relies on clinical symptoms and is easily confused with atypical Parkinsonian syndrome(APS) in the early stages. There is an urgent need for reliable biomarkers. This project aims to use metabolomics technology based on proton nuclear magnetic resonance spectroscopy to study the metabolomic characteristics of patients with PD and APS, and preliminarily screen for possible diagnostic biomarkers of PD and APS.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

July 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

July 1, 2024

Last Update Submit

July 1, 2024

Conditions

Keywords

Progressive Supranuclear PalsyMultiple System AtrophyParkinson Diseasenuclear magnetic resonance

Outcome Measures

Primary Outcomes (1)

  • metabolite

    baseline

Study Arms (4)

Parkinson's disease

Age range from 45 to 80 years old; ② Patients with idiopathic Parkinson's disease who meet the diagnostic criteria of the International Committee on Motor Disorders (MDS) for Parkinson's disease (2015); ③ Classification criteria for subtypes of Parkinson's disease: Tremor predominant type: According to the MDS-UPDRS score, the ratio of average tremor score to average PIGD score is ≥ 1.15 PIGD type: According to the MDS-UPDRS score, the ratio of average tremor score to average PIGD score is ≤ 0.9

progressive supranuclear palsy

PSP inclusion criteria ① Age range from 45 to 80 years old; ② PSP patients who meet the diagnostic criteria for progressive supranuclear palsy in China (2016) or the diagnostic criteria for progressive supranuclear palsy in the International Society for Parkinson's Disease and Movement Disorders (MDS) (2017)

healthy control

Volunteers aged 45-80 who are matched for age, gender, and underlying diseases, have no neurological disorders, and have not Take any medication.

multiple system atrophy

MSA inclusion criteria * Age range from 45 to 80 years old; ② Meets the Chinese expert consensus on the diagnostic criteria for multiple system atrophy (2017) or the International Society for Parkinson's Disease and Movement Disorders (MDS) diagnostic criteria for multiple system atrophy (2022) ③ MSA subtype grouping: MSA is divided into MSA-P and MSA-C subtypes based on the severity of initial and/or motor symptoms, with Patients with Parkinson's syndrome as the main type are MSA-P, while patients with cerebellar syndrome as the main type are MSA-C.

Eligibility Criteria

Age45 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

from Fujian Medical University Union Hospital

You may qualify if:

  • Age range from 45 to 80 years old;
  • Age range from 45 to 80 years old;
  • Meets the Chinese expert consensus on the diagnostic criteria for multiple system atrophy (2017) or the International Society for Parkinson\'s Disease and Movement Disorders (MDS) diagnostic criteria for multiple system atrophy (2022)
  • ③ MSA subtype grouping: MSA is divided into MSA-P and MSA-C subtypes based on the severity of initial and/or motor symptoms, with Patients with Parkinson\'s syndrome as the main type are MSA-P, while patients with cerebellar syndrome as the main type are MSA-C.
  • Age range from 45 to 80 years old;
  • ② PSP patients who meet the diagnostic criteria for progressive supranuclear palsy in China (2016) or the diagnostic criteria for progressive supranuclear palsy in the International Society for Parkinson\'s Disease and Movement Disorders (MDS) (2017)
  • (3) Selection criteria for Parkinson\'s disease case group
  • Age range from 45 to 80 years old;
  • Patients with idiopathic Parkinson\'s disease who meet the diagnostic criteria of the International Committee on Motor Disorders (MDS) for Parkinson\'s disease (2015);
  • Classification criteria for subtypes of Parkinson\'s disease:
  • Tremor predominant type: According to the MDS-UPDRS score, the ratio of average tremor score to average PIGD score is ≥ 1.15
  • PIGD type: According to the MDS-UPDRS score, the ratio of average tremor score to average PIGD score is ≤ 0.9

You may not qualify if:

  • ① Hereditary Parkinson\'s syndrome, secondary Parkinson\'s syndrome.
  • After deep brain stimulation (DBS) surgery.
  • Have a history of malignant tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Conditions

Supranuclear Palsy, ProgressiveMultiple System AtrophyParkinson Disease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesNeurodegenerative DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPrimary DysautonomiasAutonomic Nervous System DiseasesSynucleinopathiesParkinsonian Disorders

Central Study Contacts

Ying Chen associate chief physician, Master

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 8, 2024

Study Start

February 1, 2023

Primary Completion

June 30, 2024

Study Completion

February 1, 2026

Last Updated

July 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations