Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000, China
Location status: Recruiting
Recruiting
NCT Number: NCT05527067
A Registered 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
30 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Data Collection
OtherNeuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected
Primary outcomes
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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.
Secondary outcomes
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H&Y stage
Time frame: Baseline
The Hoehn and Yahr （H&Y)
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MoCA scores
Time frame: Baseline
The Montreal Cognitive Assessment (MoCA)
-
ACE-III scores
Time frame: Baseline
Addenbrooke's Cognitive Examination (ACE) score
-
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.
-
HRV (ms)
Time frame: Baseline
Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.
-
Plasma α-synuclein levels (ng/ml)
Time frame: Baseline
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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.
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PAF (Hz)
Time frame: Baseline
The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
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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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Fujian Medical University Union Hospital
Other
Registry information
Official study title
A Registered Observational Cohort Study on α-Synucleinopathy
Important dates
- Study start
- 2021
- Primary completion
- 2030
- Study completion
- 2030
- First posted
- Sep 2, 2022
- Registry last updated
- Mar 23, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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