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A Registered Cohort Study on α-Synucleinopathy

A Registered Observational Cohort Study on α-Synucleinopathy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05527067
Enrollment
500
Registered
2022-09-02
Start date
2021-09-01
Completion date
2030-06-30
Last updated
2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

α-synucleinopathy

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.

Interventions

OTHERData collection

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

Sponsors

Fujian Medical University Union Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
UPDRS /UMSARS scoresBaselineDisease 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

MeasureTime frameDescription
H&Y stageBaselineThe Hoehn and Yahr (H&Y)
MoCA scoresBaselineThe Montreal Cognitive Assessment (MoCA)
Mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg)BaselineMean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure.
ACE-III scoresBaselineAddenbrooke's Cognitive Examination (ACE) score
Plasma α-synuclein levels (ng/ml)Baseline
VicBaselineThe intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
PAF (Hz)BaselineThe alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
HRV (ms)BaselineHeart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.

Countries

China

Contacts

Primary ContactXiaodong Pan
pxd77316@163.com0591-86218341

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026