A Registered Cohort Study on α-Synucleinopathy

Recruiting

• Conditions: α-synucleinopathy
• Interventions: Other: Data collection

• Registration Number: NCT05527067
• Lead Sponsor: Fujian Medical University Union Hospital

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.

Study Timeline

• Study Start: 2021-09-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-28
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-09-02
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23
• Primary Completion: 2030-06
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	Data collection	Healthy controls
α-synucleinopathy	Data collection	Participants with clinical diagnosis of α-synucleinopathy.

Primary Outcome Measures

Name	Time	Method
UPDRS /UMSARS scores	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.

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg)	Baseline	Mean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure.
PAF (Hz)	Baseline	The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
HRV (ms)	Baseline	Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.
Plasma α-synuclein levels (ng/ml)	Baseline
H&Y stage	Baseline	The Hoehn and Yahr （H\&Y)
ACE-III scores	Baseline	Addenbrooke's Cognitive Examination (ACE) score
MoCA scores	Baseline	The Montreal Cognitive Assessment (MoCA)
Vic	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.

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China