An Observational Study of Parkinson's Disease and Other Synucleinopathies (EASE-PD) (NCT05638815) | Clinical Trial Compass
CompletedNot Applicable
An Observational Study of Parkinson's Disease and Other Synucleinopathies (EASE-PD)
China89 participantsStarted 2021-11-23
Plain-language summary
The study is a multi-center, observational study to evaluate the feasibility of Ξ±-synuclein-related biomarkers and imaging data in the disease diagnosis and prognosis evaluation in Synucleinopathies and healthy subjects.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Age β₯ 40 years old, regardless of gender;
β. 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;
β. Hohen \& Yahr stage 1-3;
β. 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));
β. The subject or his/her legal representative is able to understand the content of the informed consent and provide a signed ICF.
β. Age β₯ 40 years old, regardless of gender;
β. 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;
β. The subject or his/her legal representative is able to understand the content of the informed consent and provide a signed ICF.
Exclusion criteria
β. Secondary Parkinsonism due to infection, vascular, drugs, poisons, trauma and other causes;
β. Malignant neoplasm (except basal or squamous cell skin cancer) diagnosed within the last 5 years;
β
What they're measuring
1
To evaluate the difference of Ξ±-synuclein-related biomarkers between patients and healthy subjects
. Those with a known mental illness or substance abuse that will cause them to be unable to cooperate;
β. 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;
β. Pregnant or lactating women;
β. Prior treatment with drugs targeting Ξ±-synuclein;
β. Received an investigational drug or device within the previous 4 weeks;
β. The results of laboratory examination and serological virological examination are not suitable for enrollment according to the judgment of the investigator;