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CompletedNCT05638815EASE-PDUpdated Nov 22, 2023

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

An observational study in Parkinson's Disease and Multiple System Atrophy, sponsored by SciNeuro. Completed at 4 sites in China. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by SciNeuro · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
89
Ages
40 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Parkinson's Disease
  • Multiple System Atrophy

Keywords

  • α-synuclein
  • synucleinopathies
  • Parkinson's Disease
  • Multiple System Atrophy
03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's enrollment of 89 is close to the median of 96 across 1,085 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

SciNeuro is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

included in the eligibility criteria

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
89 participants (actual)
Patient registry
No

Groups and cohorts

  • Parkinson's Disease (PD)
  • Multiple System Atrophy (MSA)
  • Health volunteers
06

What researchers measure

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Attempt to evaluate the correlation between α-synuclein and disease progression by comparing α-synuclein levels at baseline

    Time frame: 6 months, and 12 months

  2. To evaluate the differences of imaging-related indicators in PD, MSA, and their correlation with the disease by brain positron emission tomography (PET)

    Time frame: 12 months

  3. To evaluate the correlation between α-synuclein levels and imaging data.

    Time frame: 12 months

07

Study locations

4 sites
  • 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, China
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Jul 2023, 19 months.

Of 60 industry-sponsored observational studies under Parkinson Disease, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's 19 months is below that.

Counting every sponsor, half of 438 studies reached it within 47 months; a quarter within 22 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2022
First posted
Dec 6, 2022
StartActual
Nov 23, 2021
Primary completionActual
Jul 10, 2023
CompletionActual
Jul 10, 2023
Last update
Nov 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05638815
Lead sponsor
SciNeuro
Responsible party
Sponsor
First posted
Dec 6, 2022
Start date
Nov 23, 2021
Primary completion
Jul 10, 2023
Completion
Jul 10, 2023
Last update
Nov 22, 2023

Study contacts

Shengdi Chen, MD,PHD
principal investigator · Neurology Department in Ruijin Hospital Shanghai JiaoTong University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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