ClinicalTrials.gov record NCT07644013
Prospective Multicenter Registry Study of Multiple System Atrophy in China
Clinical Features and Natural History of Multiple System Atrophy: A Prospective Multicenter Registry Study in China
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, multicenter registry study that aims to describe clinical features and how multiple system atrophy (MSA) progresses in Chinese patients. Parkinson disease patients and healthy controls may also be included for comparison. Data are collected during clinic visits and by review of medical records, and may include clinical scales, autonomic testing, neuroimaging, laboratory tests, and stored biospecimens with longitudinal follow-up.
What it is studying. To describe the clinical characteristics and natural history of MSA in Chinese patients, compare MSA subtypes, identify clinical and paraclinical factors associated with disease progression and prognosis, and create a longitudinal cohort for future biomarker validation and clinical trial planning.
What the researchers hope to learn. Characterize clinical features and longitudinal course of MSA in China; compare MSA-P and MSA-C subtypes; identify factors linked to progression and prognosis; establish a longitudinal platform for biomarker validation and clinical trial design.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Multiple system atrophy is a rare, rapidly progressive neurodegenerative disease characterized by variable combinations of parkinsonism, cerebellar ataxia, and autonomic dysfunction. Existing natural history studies from North America, Europe, and Japan suggest that clinical phenotypes and disease progression may differ across populations. However, comprehensive multicenter prospective data from Chinese patients with multiple system atrophy remain limited. This prospective multicenter registry study aims to describe the clinical characteristics, longitudinal progression, and outcomes of Chinese patients with multiple system atrophy, to identify factors associated with disease progression and prognosis, and to establish a longitudinal cohort for future biomarker validation and clinical trial design.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patients with clinically established or clinically probable multiple system atrophy according to the 2022 Movement Disorder Society diagnostic criteria; or
- Patients with clinically established or clinically probable Parkinson disease according to the Movement Disorder Society diagnostic criteria; or
- Healthy controls or controls without hereditary or neurodegenerative diseases who voluntarily agree to participate.
- Age between 40 and 75 years.
- Ability to provide informed consent or availability of a legally authorized representative when applicable.
Exclusion criteria
- Parkinsonism that cannot be classified as Parkinson disease or multiple system atrophy at the time of evaluation.
- Clinical suspicion or diagnosis of other atypical parkinsonian syndromes, including progressive supranuclear palsy, dementia with Lewy bodies, or corticobasal syndrome.
- Secondary parkinsonism due to intracranial space-occupying lesions, normal pressure hydrocephalus, drug-induced parkinsonism, or other identifiable causes.
- Comorbid diseases that may substantially affect autonomic function, such as diabetic peripheral neuropathy or amyloidosis.
- Refusal to participate in the study or refusal to undergo routine clinical evaluations for parkinsonian syndromes.
- Psychiatric or behavioral abnormalities that preclude reliable clinical data collection or scale-based assessment.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
Multiple system atrophy is an adult-onset, progressive neurodegenerative disorder characterized by parkinsonism, cerebellar ataxia, autonomic dysfunction, and variable non-motor manifestations. The disease is pathologically associated with alpha-synuclein accumulation and neuronal and glial degeneration in multiple brain regions. Due to its rarity, clinical heterogeneity, rapid progression, and poor prognosis, large-scale prospective studies are needed to better define its natural history and to support future therapeutic development. This study is a prospective, observational, multicenter registry study conducted in China. Eligible participants will include patients with clinically established or clinically probable multiple system atrophy according to the 2022 Movement Disorder Society diagnostic criteria. Parkinson disease patients and healthy or non-neurodegenerative controls may also be enrolled for comparative analyses. Data will be collected through in-person visits, medical record review, standardized clinical scales, neurological examinations, autonomic function testing, neuroimaging, laboratory tests, and biospecimen collection. Longitudinal follow-up will be performed at prespecified time points, including alternating in-person and telephone-based assessments when applicable. Clinical scales may include the Unified Multiple System Atrophy Rating Scale, Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale, non-motor symptom scales, autonomic symptom scales, and disability measures. Neuroimaging, autonomic function tests, electrophysiological or oculomotor evaluations, and biospecimen-based analyses may be performed according to the study protocol and local clinical practice. The main objectives are to characterize the clinical features and longitudinal disease course of Chinese patients with multiple system atrophy, compare clinical characteristics between MSA-P and MSA-C subtypes, identify clinical and paraclinical factors associated with disease progression and prognosis, and establish a longitudinal platform for subsequent biomarker validation and clinical trial design.
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 informed consent, participants join a prospective registry with medical-record review and scheduled follow-up visits. Assessments include standardized clinical rating scales and neurological exams, autonomic function testing, neuroimaging, electrophysiological or oculomotor evaluations, and collection of biospecimens according to the protocol and local practice. Follow-up is at prespecified time points with alternating in-person and telephone assessments; some participants may be followed for up to 36 months. Refusing study evaluations or routine clinical assessments is an exclusion from participation.
How the study is structured. A prospective, observational multicenter registry (cohort). Participants are followed at prespecified time points with in-person clinic visits and some telephone assessments; data include standardized neurological scales, autonomic function testing, neuroimaging, routine lab tests, and biospecimen collection and storage for later analysis.
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
- Jun 1, 2025
- Primary completion
- Dec 31, 2029 (estimated)
- Study completion
- Jun 30, 2030 (estimated)
- Target enrollment
- 214 participants (estimated)
- Last updated on registry
- Jun 12, 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
- Peking University First Hospital
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.
- Yunchuang Sun, MD ✉ sychuang0805@163.com
Participating sites (1)
- Peking University First HospitalRecruiting
Beijing, Beijing Municipality, 100034 · China
- Yang Zhao · (+86)18610320188 · zhaoyang2019@pku.edu.cn
Terms used on this page · explanations by MedicalUpdates.ai
- natural history
- A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- 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.
- biomarker
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- clinical trial
- A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
- 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.
- legally authorized representative
- A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
- 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.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- biospecimen
- A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
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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