An Observational Study of Parkinson's Disease and Other Synucleinopathies (EASE-PD)

Sponsor

SciNeuro Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05638815

Collaborator

(none)

Enrollment

Locations

22.2

Anticipated Duration (Months)

22.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease Multiple System Atrophy

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

Study Type:

Observational

Actual Enrollment :

89 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Nov 23, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Parkinson's Disease (PD)
Multiple System Atrophy (MSA)
Health volunteers

Outcome Measures

Primary Outcome Measures

To evaluate the difference of α-synuclein-related biomarkers between patients and healthy subjects [12 months]

Secondary Outcome Measures

Attempt to evaluate the correlation between α-synuclein and disease progression by comparing α-synuclein levels at baseline [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) [12 months]
To evaluate the correlation between α-synuclein levels and imaging data. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

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.

Exclusion Criteria:

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;
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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei	China
2	Nanjing Brain Hospital	Nanjing	Jiangsu	China
3	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	China
4	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China