ClinicalTrials.gov record NCT07353463

Shanghai Clinical Cohort - Parkinson's Disease (Reserve)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

Shanghai Clinical Cohort - Parkinson's Disease (Reserve)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational cohort study enrolling people with Parkinson's disease (PD) and with clinically diagnosed or probable multiple system atrophy (MSA). The study plans about 600 PD and 100 MSA participants who will have standardized clinical assessments, brain imaging, electrophysiology, and provide biospecimens (blood, saliva; cerebrospinal fluid optional). Repeat assessments are scheduled every 6 months, with a target duration of 1 year.

What it is studying. The study tests whether combining clinical information, imaging, electrophysiology, biospecimens, and genetics can identify early biomarkers and precise subtypes, and whether subtyping and regular monitoring help predict disease progression and response to therapy. It also compares PD and MSA across these measures.

What the researchers hope to learn. To establish a high-quality clinical cohort and shared data resource for PD and MSA; to identify early biomarkers from multimodal data; to develop more precise clinical subtypes; to evaluate whether subtyping and longitudinal monitoring relate to disease progression, clinical features, biomarkers, imaging, and prognosis; to support translational research and future therapy development.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The goal of this observational cohort studyis to establish a high-quality clinical cohort of Parkinson's disease (PD) and multiple system atrophy (MSA) patients in Shanghai, in order to improve early diagnosis, precise subtyping, disease monitoring, and to provide a resource for translational research and novel therapy development. The main questions it aims to answer are:

  • Can multimodal data (clinical, imaging, electrophysiology, biospecimens, and genetics) help identify early biomarkers for PD and MSA?
  • Can precise subtyping and long-term monitoring predict disease progression and therapeutic response? Researchers will compare 600 PD patients and 100 MSA patients to evaluate differences in clinical features, biomarkers, imaging, and prognosis.

Participants will:

  • Provide informed consent and complete baseline demographic and medical history collection.
  • Undergo standardized clinical evaluations, including motor and non-motor symptom scales, cognitive and quality-of-life assessments.
  • Provide biological samples (blood, saliva, optional CSF).
  • Receive brain imaging (MRI, optional PET/SPECT) and electrophysiological recordings (EEG, fNIRS).
  • Participate in longitudinal follow-up visits every 6 months for repeat assessments.

This study will create a sustainable, multicenter, and sharable cohort platform to support early identification, personalized intervention, and therapeutic development for neurodegenerative diseases

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Inclusion Criteria for Clinical PD Group:
  • Patients with a clinical diagnosis of Parkinson's disease (PD) according to the _Chinese Diagnostic Criteria for Parkinson's Disease (2016 edition)_.
  • Willingness to undergo biospecimen collection, including cerebrospinal fluid (optional), blood, and saliva, and to complete neuroimaging examinations (MRI, PET/SPECT) and disease-specific clinical assessments.
  • Provision of written informed consent
  • Inclusion Criteria for Clinical MSA Group:
  • Patients with a clinical diagnosis or clinically probable multiple system atrophy (MSA) according to the Chinese Expert Consensus on the Diagnostic Criteria for MSA (2022).
  • Willingness to undergo biospecimen collection, including cerebrospinal fluid (optional), blood, and saliva, and to complete neuroimaging examinations (MRI, PET/SPECT) and disease-specific clinical assessments.
  • Provision of written informed consent.

Exclusion criteria

  • for All Participants:
  • Patients with an unclear or uncertain diagnosis.
  • History of stroke, head trauma, hydrocephalus, brain tumor, intracranial hypertension, or intracranial surgery.
  • Evidence of intracranial organic lesions on CT/MRI.
  • Severe anxiety, depression, or schizophrenia.
  • Severe comorbidities involving the heart, lungs, liver, kidneys, endocrine system, or hematological system.
  • Presence of aphasia, severe dysarthria, or other conditions that significantly impair clinical assessments.
  • Anticipated poor compliance.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After giving written consent, participants complete medical history and standardized clinical evaluations (motor and non-motor symptom scales, cognitive and quality-of-life assessments). They provide blood and saliva samples and may choose to give cerebrospinal fluid (spinal tap) for research. Participants have brain imaging (MRI; PET/SPECT optional) and electrophysiological recordings (EEG, fNIRS). Repeat assessments and sample collection occur every 6 months with follow-up through 12 months.

How the study is structured. A prospective observational cohort study with two groups (about 600 people with PD and 100 people with clinically diagnosed or probable MSA). Participants complete baseline clinical evaluations (motor and non-motor scales, cognitive and quality-of-life measures), provide biospecimens (blood, saliva, optional cerebrospinal fluid), receive brain imaging (MRI; PET/SPECT optional), and undergo electrophysiological recordings (EEG, fNIRS). Assessments are repeated every 6 months through the study's 1-year target duration to track changes over time.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

Important dates

Study start
Apr 1, 2025
Primary completion
Dec 31, 2026 (estimated)
Study completion
Dec 31, 2026 (estimated)
Target enrollment
700 participants (estimated)
Last updated on registry
Mar 5, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Ruijin Hospital
Collaborators
  • Huashan Hospital
  • Shanghai Sunshine Rehabilitation Center
  • Longhua Hospital
  • Shanghai Municipal Hospital of Traditional Chinese Medicine
  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineRecruiting

    Shanghai, 200025 · China

Terms used on this page · explanations by MedicalUpdates.ai

cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
biospecimens
A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
PET
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
CT
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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