Parkinson's DiseaseEASE-PDNCT05638815
An Observational Study of Parkinson's Disease and Other Synucleinopathies (EASE-PD)
An observational study of Parkinson's Disease and Multiple System Atrophy, run by SciNeuro at 4 sites in China.
Trial summary
The study is a multi-center, observational study to evaluate the feasibility of α-synuclein-related biomarkers and imaging data in the disease diagnosis and prognosis evaluation in Synucleinopathies and healthy subjects. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Multiple System Atrophy
- How many people
- 89 participants
- Where
- 4 sitesChina
- Study dates
- 23 Nov 2021to 10 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: included in the eligibility criteria
Who may be able to join
- PD subjects must meet the following criteria to be eligible:
- Age ≥ 40 years old, regardless of gender;
- Primary PD is diagnosed according to MDS Clinical Diagnostic Criteria for Parkinson's Disease of the International Movement Disorders Association (MDS) in 2015 and the Diagnostic Criteria of Parkinson's Disease in China in 2016;
- Hohen \& Yahr stage 1-3;
- Receive standard treatment for at least 4 weeks before the screening visit (standard treatment is listed in the Chinese Guidelines for the Treatment of Parkinson's Disease (Fourth Edition));
- The subject or his/her legal representative is able to understand the content of the informed consent and provide a signed ICF.
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- MSA subjects must meet the following criteria to be eligible:
- Age ≥ 40 years old, regardless of gender;
- Patients with probable and possible MSA are diagnosed according to the Second Consensus Statement on the Diagnosis of Multiple System Atrophy and the Chinese Expert Consensus on the Diagnostic Criteria of Multiple System Atrophy in 2018;
- The subject or his/her legal representative is able to understand the content of the informed consent and provide a signed ICF.
- Healthy subjects must meet the following criteria to be eligible:
- Age ≥ 40 years old, regardless of gender;
- Volunteers who are in good health for their age as determined by clinical examination at the time of screening and who are free from dyskinesia as determined by a complete neurological assessment and from serious systemic disease as determined by a complete history;
- Be able to understand the content of informed consent and agree to sign ICF.
Who cannot join
- Excluded if any of the following criteria is met:
- Secondary Parkinsonism due to infection, vascular, drugs, poisons, trauma and other causes;
- Malignant neoplasm (except basal or squamous cell skin cancer) diagnosed within the last 5 years;
- Those with a known mental illness or substance abuse that will cause them to be unable to cooperate;
- Patients with severe depression or suicidal behavior (including active attempt, interrupted attempt or attempted attempt) or suicidal thoughts in the past 6 months according to the clinical judgment of the investigator;
- Pregnant or lactating women;
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- Prior treatment with drugs targeting α-synuclein;
- Received an investigational drug or device within the previous 4 weeks;
- The results of laboratory examination and serological virological examination are not suitable for enrollment according to the judgment of the investigator;
- Other conditions judged by the investigator as not suitable for inclusion.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Nanjing Brain Hospital
Nanjing, Jiangsu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
About this study
Official title: An Observational Study to Explore the Role of Alpha-Synuclein-related Biomarkers in the Diagnosis and Disease Evaluation of Parkinson's Disease and Other Synucleinopathies
The study is a multi-center, observational study to evaluate the feasibility of α-synuclein-related biomarkers and imaging data in the disease diagnosis and prognosis evaluation in Synucleinopathies and healthy subjects.
Read the detailed description
In the study, a total number of no more than 100 subjects are planned to be enrolled.
Subjects who are eligible for enrollment will be enrolled in the study after signing the informed consent form (ICF) and undergo 3 visits, including the baseline visit (the day of first blood sample collection), visit 1 (day 183 post-enrollment), and visit 2 (day 366 post-enrollment).
- Conditions
- Parkinson's Disease, Multiple System Atrophy
- Keywords
- α-synuclein, synucleinopathies, Parkinson's Disease, Multiple System Atrophy
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, Parkinson Disease 4, Autosomal Dominant Lewy Body, Synucleinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease (PD) | Not described | |
| Multiple System Atrophy (MSA) | Not described | |
| Health volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the difference of α-synuclein-related biomarkers between patients and healthy subjects
Measured: 12 months
Secondary outcomes (3)
Attempt to evaluate the correlation between α-synuclein and disease progression by comparing α-synuclein levels at baseline
Measured: 6 months, and 12 months
To evaluate the differences of imaging-related indicators in PD, MSA, and their correlation with the disease by brain positron emission tomography (PET)
Measured: 12 months
To evaluate the correlation between α-synuclein levels and imaging data.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start23 Nov 2021
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- SciNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shengdi Chen, MD,PHD, Principal investigator, Neurology Department in Ruijin Hospital Shanghai JiaoTong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638815
- Sponsor's protocol ID
- SNP704
- Acronym
- EASE-PD
- Status last verified
- Nov 2023
- First submitted
- 22 Mar 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Explore the Role of Alpha-Synuclein-related Biomarkers in the Diagnosis and Disease Evaluation of Parkinson's Disease and Other Synucleinopathies
- ClinicalTrials.gov ID
- NCT05638815
- Acronym / sponsor ID
- EASE-PD / SNP704
- Conditions
- Parkinson's Disease, Multiple System Atrophy
- Keywords
- α-synuclein, synucleinopathies, Parkinson's Disease, Multiple System Atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- SciNeuroIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 6 Dec 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.
The study is a multi-center, observational study to evaluate the feasibility of α-synuclein-related biomarkers and imaging data in the disease diagnosis and prognosis evaluation in Synucleinopathies and healthy subjects.
Detailed description
In the study, a total number of no more than 100 subjects are planned to be enrolled.
Subjects who are eligible for enrollment will be enrolled in the study after signing the informed consent form (ICF) and undergo 3 visits, including the baseline visit (the day of first blood sample collection), visit 1 (day 183 post-enrollment), and visit 2 (day 366 post-enrollment).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease (PD) | – | – |
| Multiple System Atrophy (MSA) | – | – |
| Health volunteers | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- included in the eligibility criteria
Key inclusion criteria (14 listed)
- PD subjects must meet the following criteria to be eligible:
- MSA subjects must meet the following criteria to be eligible:
- Healthy subjects must meet the following criteria to be eligible:
Key exclusion criteria (10 listed)
- Excluded if any of the following criteria is met:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the difference of α-synuclein-related biomarkers between patients and healthy subjects
Time frame: 12 months
3 secondary outcomes
Attempt to evaluate the correlation between α-synuclein and disease progression by comparing α-synuclein levels at baseline
Time frame: 6 months, and 12 months
To evaluate the differences of imaging-related indicators in PD, MSA, and their correlation with the disease by brain positron emission tomography (PET)
Time frame: 12 months
To evaluate the correlation between α-synuclein levels and imaging data.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- SciNeuro official websiteLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Shengdi Chen, MD,PHD principal investigator
Neurology Department in Ruijin Hospital Shanghai JiaoTong University School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Multiple System Atrophy, run by SciNeuro at 4 sites 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 14 inclusion and 10 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: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the difference of α-synuclein-related biomarkers between patients and healthy subjects (time frame: 12 months). 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 22 Nov 2023.