A Registered Cohort Study on α-Synucleinopathy

NCT05527067 | Recruiting

• 1 other identifier: Cohort-PDS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

α-synucleinopathy

Outcome Measures

Primary Outcomes (1)

• 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 (9)

• H&Y stage

  Baseline

• MoCA scores

  Baseline

• ACE-III scores

  Baseline

• Mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg)

  Baseline

• HRV (ms)

  Baseline

Study Arms (2)

α-synucleinopathy

Participants with clinical diagnosis of α-synucleinopathy.

Other: Data collection

Healthy controls

Healthy controls

Other: Data collection

Interventions

Data collection OTHER

Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected

α-synucleinopathy

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Xiaodong Pan

CONTACT

0591-86218341; pxd77316@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: September 2, 2022
• Study Start: September 1, 2021
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: March 23, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)