Clinical trial NCT05638815: An Observational Study of Parkinson's Disease and Other Synucleinopathies (EASE-PD)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Multiple System Atrophy
Keywords: α-synuclein
synucleinopathies
Parkinson's Disease
Multiple System Atrophy
Lead sponsor: SciNeuro
Sponsor class: INDUSTRY
First posted: 2022-12-06
Enrollment: 89
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: included in the eligibility criteria

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.

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).

Eligibility criteria: Inclusion Criteria:

* PD subjects must meet the following criteria to be eligible:

  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:

* Excluded if any of the following criteria is met:

  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.

Primary outcomes:
measure: To evaluate the difference of α-synuclein-related biomarkers between patients and healthy subjects
timeFrame: 12 months
Secondary outcomes:
measure: Attempt to evaluate the correlation between α-synuclein and disease progression by comparing α-synuclein levels at baseline
timeFrame: 6 months, and 12 months
measure: To evaluate the differences of imaging-related indicators in PD, MSA, and their correlation with the disease by brain positron emission tomography (PET)
timeFrame: 12 months
measure: To evaluate the correlation between α-synuclein levels and imaging data.
timeFrame: 12 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Neurology Department in Ruijin Hospital Shanghai JiaoTong University School of Medicine
name: Shengdi Chen, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: