A Registered Cohort Study on α-Synucleinopathy

March 22, 2023 updated by: Fujian Medical University Union Hospital

A Registered Observational Cohort Study on α-Synucleinopathy

α-Synucleinopathy is a cluster of neurodegenerative disease with motor and non-motor symptom. The data to be collected is intended to help healthcare providers make important medical decisions concerning α-synucleinopathy, through an enhanced understanding of the natural history, progression and multi-omics datasets of α-synucleinopathy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

α-Synucleinopathy is a cluster of neurodegenerative disease with motor and non-motor symptom, including Parkinson's disease (PD), multiple system atrophy (MSA) and dementia with lewy bodies (DLB). The data to be collected is intended to help healthcare providers make important medical decisions concerning α-synucleinopathy, through an enhanced understanding of the natural history, progression and multi-omics datasets of α-synucleinopathy. Datas will be accumulated retrospectively at research entry and prospectively during follow up.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with a clinical diagnosis of PD, DLB and MSA.

Description

Inclusion Criteria:

  • Participants with a clinical diagnosis of primary α-synucleinopathy
  • Unrelated healthy controls

Exclusion Criteria:

  • Patients with secondary α-synucleinopathy that cannot be excluded.
  • Patients with other neurological disorders.
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
Other: Data collection
Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected
α-synucleinopathy
Participants with clinical diagnosis of α-synucleinopathy.
Other: Data collection
Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UPDRS /UMSARS scores
Time Frame: Baseline
Disease severity was evaluated by the neurologist using the united Parkinson's disease rating scale (UPDRS) or united multiple system atrophy rating scale (UMSARS) separately as diagnosed.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MoCA scores
Time Frame: Baseline
The Montreal Cognitive Assessment (MoCA)
Baseline
ACE-III scores
Time Frame: Baseline
Addenbrooke's Cognitive Examination (ACE) score
Baseline
HRV (ms)
Time Frame: Baseline
Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.
Baseline
Vic
Time Frame: Baseline
The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
Baseline
PAF (Hz)
Time Frame: Baseline
The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
Baseline
H&Y stage
Time Frame: Baseline
The Hoehn and Yahr （H&Y)
Baseline
Mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg)
Time Frame: Baseline
Mean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure.
Baseline
Plasma α-synuclein levels (ng/ml)
Time Frame: Baseline
Baseline
Vic
Time Frame: 1 year after Baseline
The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
1 year after Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Anticipated)

June 1, 2030

Study Completion (Anticipated)

June 1, 2030

Study Registration Dates

First Submitted

August 28, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cohort-PDS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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