Shanghai Clinical Cohort - Parkinson's Disease (Reserve)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Parkinson's Disease (PD), Multiple System Atrophy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Primary outcome measures
- Change from baseline in motor symptom severity assessed by MDS-UPDRS Part III [Time frame: From baseline through 6-month and 12-month follow-up assessments]
- Change from baseline in Hoehn & Yahr stage [Time frame: From baseline through 6-month and 12-month follow-up assessments]
- Change from baseline in Brief Pain Inventory (BPI) pain severity score [Time frame: From baseline through 6-month and 12-month follow-up assessments]
- Change from baseline in REM Sleep Behavior Disorder Questionnaire-Hong Kong (RBDQ-HK) score [Time frame: From baseline through 6-month and 12-month follow-up assessments]
- Change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLSS) score [Time frame: From baseline through 6-month and 12-month follow-up assessments]
- Change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score [Time frame: From baseline through 6-month and 12-month follow-up assessments]
- Change from baseline in Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT) score [Time frame: From baseline through 6-month and 12-month follow-up assessments]
- Change from baseline in Epworth Sleepiness Scale (ESS) score [Time frame: From baseline through 6-month and 12-month follow-up assessments]
- Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score [Time frame: From baseline through 6-month and 12-month follow-up assessments]
- Change from baseline in Hamilton Anxiety Rating Scale (HAMA) score [Time frame: From baseline through 6-month and 12-month follow-up assessments]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07353463 · Parkinson's Disease Cohort · SHDC2025CCS043