A Registered Cohort Study on α-Synucleinopathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Registered Observational Cohort Study on α-Synucleinopathy

Conditions
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α-synucleinopathy

Intervention / Treatment
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* Other: Data collection
* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| α-synucleinopathy<br>Participants with clinical diagnosis of α-synucleinopathy. | Other: Data collection<br>* Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected<br>|
| Healthy controls<br>Healthy controls | Other: Data collection<br>* Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

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