A Registered Cohort Study on α-Synucleinopathy | NCT05527067

Studies
A Registered Cohort Study on α-Synucleinopathy

NCT05527067

Sponsor

Fujian Medical University Union Hospital

Status

Recruiting

Last Update Posted

Mar 23, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

α-synucleinopathy

Interventions

Data collection
Data collection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Jun 2030Estimated

Completion Date

Jun 2030Estimated

First Submitted Date

Aug 28, 2022

First Submission Date that Met QC Criteria

Aug 30, 2022

First Posted Date

Sep 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2023

Last Update Posted Date

Mar 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
α-synucleinopathy		Participants with clinical diagnosis of α-synucleinopathy.	Other: Data collection
Healthy controls		Healthy controls	Other: Data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other	Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected	α-synucleinopathy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
UPDRS /UMSARS scores	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 Outcomes

Measure	Description	Time Frame
H&Y stage	The Hoehn and Yahr （H&Y)	Baseline
MoCA scores	The Montreal Cognitive Assessment (MoCA)	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaodong Pan	Contact	0591-86218341		pxd77316@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Medical University Union Hospital	Recruiting	Fuzhou	Fujian	350000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided