An Observational Study of Parkinson's Disease and Other Synucleinopathies (EASE-PD)
NCT ID: NCT05638815
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
89 participants
OBSERVATIONAL
2021-11-23
2023-07-10
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Parkinson's Disease (PD)
No interventions assigned to this group
Multiple System Atrophy (MSA)
No interventions assigned to this group
Health volunteers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Age ≥ 40 years old, regardless of gender;
2. 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;
3. Hohen \& Yahr stage 1-3;
4. 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));
5. The subject or his/her legal representative is able to understand the content of the informed consent and provide a signed ICF.
* MSA subjects must meet the following criteria to be eligible:
1. Age ≥ 40 years old, regardless of gender;
2. 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;
3. 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:
1. Age ≥ 40 years old, regardless of gender;
2. 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;
3. Be able to understand the content of informed consent and agree to sign ICF.
Exclusion Criteria
1. Secondary Parkinsonism due to infection, vascular, drugs, poisons, trauma and other causes;
2. Malignant neoplasm (except basal or squamous cell skin cancer) diagnosed within the last 5 years;
3. Those with a known mental illness or substance abuse that will cause them to be unable to cooperate;
4. 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;
5. Pregnant or lactating women;
6. Prior treatment with drugs targeting α-synuclein;
7. Received an investigational drug or device within the previous 4 weeks;
8. The results of laboratory examination and serological virological examination are not suitable for enrollment according to the judgment of the investigator;
9. Other conditions judged by the investigator as not suitable for inclusion.
40 Years
ALL
Yes
Sponsors
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SciNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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Shengdi Chen, MD,PHD
Role: PRINCIPAL_INVESTIGATOR
Neurology Department in Ruijin Hospital Shanghai JiaoTong University School of Medicine
Locations
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Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Related Links
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SciNeuro official website
Other Identifiers
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SNP704
Identifier Type: -
Identifier Source: org_study_id