α-synucleinopathyNCT05527067
A Registered Cohort Study on α-Synucleinopathy
An observational study of α-synucleinopathy, run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- α-synucleinopathy
- What is being tested?
- Data collection
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to Jun 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with a clinical diagnosis of PD, DLB and MSA.
Who may be able to join
- Participants with a clinical diagnosis of primary α-synucleinopathy
- Unrelated healthy controls
Who cannot join
- Patients with secondary α-synucleinopathy that cannot be excluded.
- Patients with other neurological disorders.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Xiaodong Pan, 0591-86218341, pxd77316@163.com
About this study
Official title: A Registered Observational 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.
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.
- Conditions
- α-synucleinopathy
- Being tested
- Data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected
Data collectionOther
Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected
| Study group | Role | What they receive |
|---|---|---|
| α-synucleinopathy | Participants with clinical diagnosis of α-synucleinopathy. Receives: Other: Data collection | |
| Healthy controls | Healthy controls Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (9)
H&Y stage
The Hoehn and Yahr （H\&Y)
Measured: Baseline
MoCA scores
The Montreal Cognitive Assessment (MoCA)
Measured: Baseline
ACE-III scores
Addenbrooke's Cognitive Examination (ACE) score
Measured: 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.
Measured: Baseline
HRV (ms)
Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.
Measured: Baseline
Plasma α-synuclein levels (ng/ml)
Measured: Baseline
Vic
The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
Measured: Baseline
PAF (Hz)
The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
Measured: Baseline
Vic
The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
Measured: 1 year after Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Sep 2021
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for α-synucleinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527067
- Sponsor's protocol ID
- Cohort-PDS
- Status last verified
- Aug 2022
- First submitted
- 28 Aug 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registered Observational Cohort Study on α-Synucleinopathy
- ClinicalTrials.gov ID
- NCT05527067
- Acronym / sponsor ID
- Cohort-PDS
- Conditions
- α-synucleinopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| α-synucleinopathy | – | Other: Data collectionParticipants with clinical diagnosis of α-synucleinopathy. |
| Healthy controls | – | Other: Data collectionHealthy controls |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a clinical diagnosis of PD, DLB and MSA.
Key inclusion criteria (2 listed)
- Participants with a clinical diagnosis of primary α-synucleinopathy
- Unrelated healthy controls
Key exclusion criteria (3 listed)
- Patients with secondary α-synucleinopathy that cannot be excluded.
- Patients with other neurological disorders.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionNeuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected | Other | α-synucleinopathy |
| Data collectionNeuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected | Other | Healthy controls |
Primary outcome
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.
9 secondary outcomes
H&Y stage
Time frame: Baseline
MoCA scores
Time frame: Baseline
ACE-III scores
Time frame: Baseline
Mean arterial pressure after 3 minutes of upright posture versus decubitus position (mmHg)
Time frame: Baseline
HRV (ms)
Time frame: Baseline
Plasma α-synuclein levels (ng/ml)
Time frame: Baseline
Vic
Time frame: Baseline
PAF (Hz)
Time frame: Baseline
Vic
Time frame: 1 year after Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of α-synucleinopathy, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Pan (0591-86218341, pxd77316@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS /UMSARS scores (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.