Shanghai Clinical Cohort - Parkinson's Disease (Reserve)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRuijin Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
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).
Disqualifiers
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.
Trial population
The study population consists of patients with Parkinson's disease (PD) and multiple system atrophy (MSA) recruited from outpatient and inpatient clinics at Ruijin Hospital and collaborating tertiary medical centers in Shanghai. Approximately 600 clinically diagnosed PD patients and 100 clinically diagnosed or probable MSA patients will be enrolled. All participants must meet established Chinese diagnostic criteria, agree to provide biospecimens (blood, saliva, optional CSF), undergo neuroimaging and electrophysiological testing, and complete standardized clinical assessments. Patients with unclear diagnoses, significant comorbidities, or poor compliance will be excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
700 Participants
are grouped into 2 trial groupsGroup A: Parkinson's Disease Cohort
Group B: Multiple System Atrophy Cohort
Trial outcomes
Primary outcomes
1
Change from baseline in motor symptom severity assessed by MDS-UPDRS Part III
Motor symptom severity will be assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III; range 0-132, higher scores indicate worse motor impairment). The primary outcome is the change from baseline score.
Time frame
From baseline through 6-month and 12-month follow-up assessments2
Change from baseline in Hoehn & Yahr stage
Disease severity will be assessed using the Hoehn \& Yahr staging scale, which classifies Parkinson's disease severity on a scale from Stage 1 to Stage 5, with higher stages indicating more advanced disease. The secondary outcome is the change in Hoehn \& Yahr stage from baseline.
Time frame
From baseline through 6-month and 12-month follow-up assessments3
Change from baseline in Brief Pain Inventory (BPI) pain severity score
Pain severity will be assessed using the Brief Pain Inventory (BPI) pain severity subscale, with scores ranging from 0 to 10. Higher scores indicate more severe pain. The secondary outcome is the change from baseline in BPI pain severity score.
Time frame
From baseline through 6-month and 12-month follow-up assessments4
Change from baseline in REM Sleep Behavior Disorder Questionnaire-Hong Kong (RBDQ-HK) score
REM sleep behavior disorder symptoms will be assessed using the REM Sleep Behavior Disorder Questionnaire-Hong Kong (RBDQ-HK), with total scores ranging from 0 to 100. Higher scores indicate more severe RBD symptoms. The secondary outcome is the change from baseline in RBDQ-HK score.
Time frame
From baseline through 6-month and 12-month follow-up assessmentsSponsors and contacts
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Ruijin Hospital
Lead sponsor
Huashan Hospital
Collaborator
Shanghai Sunshine Rehabilitation Center
Collaborator
Longhua Hospital
Collaborator
Shanghai Municipal Hospital of Traditional Chinese Medicine
Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborator
Source ClinicalTrials.gov