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

NCT05638815 | Completed

• 1 other identifier: SNP704
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 4

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.

Conditions

Parkinson's Disease; Multiple System Atrophy

Keywords

α-synuclein; synucleinopathies; Parkinson's Disease; Multiple System Atrophy

Outcome Measures

Primary Outcomes (1)

• To evaluate the difference of α-synuclein-related biomarkers between patients and healthy subjects

  12 months

Secondary Outcomes (3)

• 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

Study Arms (3)

Parkinson's Disease (PD)

Multiple System Atrophy (MSA)

Health volunteers

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

included in the eligibility criteria

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• SciNeuro: lead

Study Sites (4)

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Nanjing Brain Hospital

Nanjing, Jiangsu, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Related Links

• SciNeuro official website

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Parkinson Disease 4, Autosomal Dominant Lewy Body; Synucleinopathies

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Shengdi Chen, MD,PHD

  Neurology Department in Ruijin Hospital Shanghai JiaoTong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: December 6, 2022
• Study Start: November 23, 2021
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)