ClinicalTrials.gg
RecruitingNCT05527067Updated Mar 23, 2023

A Registered Cohort Study on α-Synucleinopathy

An observational study in α-synucleinopathy, sponsored by Fujian Medical University Union Hospital. Recruiting at 1 site in China. Open to participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-23.

Sponsored by Fujian Medical University Union Hospital · Observational

From the registry’s dates

  • Started Sep 2021; still recruiting 5 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
30 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • α-synucleinopathy

Browse trials for

03

In context

Synucleinopathies

38 studies on the registry are indexed under Synucleinopathies; 23 are open to participants now.

This study's planned enrollment of 500 is above the median of 100 across 16 observational studies indexed under Synucleinopathies.

Browse Synucleinopathies studies →

Lead sponsor

Fujian Medical University Union Hospital is the lead sponsor of 109 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with secondary α-synucleinopathy that cannot be excluded.
  • Patients with other neurological disorders.
  • Pregnant or lactating women.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • α-synucleinopathy

    Participants with clinical diagnosis of α-synucleinopathy.

    Other: Data collection

  • Healthy controls

    Healthy controls

    Other: Data collection

Interventions

  • OtherData collection

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

  • OtherData collection

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

06

What researchers measure

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.

    Time frame: Baseline

Secondary outcomes

  1. H&Y stage

    The Hoehn and Yahr (H\&Y)

    Time frame: Baseline

  2. MoCA scores

    The Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline

  3. ACE-III scores

    Addenbrooke's Cognitive Examination (ACE) score

    Time frame: Baseline

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

    Mean arterial pressure was calculated as ⅓ pulse pressure + diastolic pressure.

    Time frame: Baseline

  5. HRV (ms)

    Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.

    Time frame: Baseline

  6. Plasma α-synuclein levels (ng/ml)

    Time frame: Baseline

  7. Vic

    The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.

    Time frame: Baseline

  8. PAF (Hz)

    The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.

    Time frame: Baseline

  9. Vic

    The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.

    Time frame: 1 year after Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2021 (actual). Primary completion is estimated for Jun 2030, 105 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2022
First posted
Sep 2, 2022
StartActual
Sep 1, 2021
Primary completionEst.
Jun 2030
CompletionEst.
Jun 2030
Last update
Mar 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05527067
Responsible party
Sponsor
First posted
Sep 2, 2022
Start date
Sep 1, 2021
Primary completion
Jun 2030 (estimated)
Completion
Jun 2030 (estimated)
Last update
Mar 23, 2023

Study contacts

Xiaodong Pan
Contact
pxd77316@163.com
0591-86218341

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion