Shanghai Clinical Cohort - Parkinson's Disease (Reserve)

NCT07353463 | Recruiting DMC

• 2 other identifiers: Parkinson's Disease CohortSHDC2025CCS043
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple System Atrophy; Parkinson's Disease (PD)

Keywords

observational cohort study; multimodal data; subtyping; long-term monitoring

Outcome Measures

Primary Outcomes (13)

• 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.

  From baseline through 6-month and 12-month follow-up assessments

• 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.

  From baseline through 6-month and 12-month follow-up assessments

• 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.

  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

  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.

  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

  Restless legs syndrome symptom severity will be assessed using the International Restless Legs Syndrome Study Group Rating Scale (IRLSS), with scores ranging from 0 to 40. Higher scores indicate more severe symptoms. The secondary outcome is the change from baseline in IRLSS score.

  From baseline through 6-month and 12-month follow-up assessments

• Change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score

  Olfactory function will be assessed using the University of Pennsylvania Smell Identification Test (UPSIT), with scores ranging from 0 to 40. Lower scores indicate worse olfactory function. The secondary outcome is the change from baseline in UPSIT score.

  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

  Autonomic dysfunction will be assessed using the Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT), with total scores ranging from 0 to 69. Higher scores indicate more severe autonomic dysfunction. The secondary outcome is the change from baseline in SCOPA-AUT score.

  From baseline through 6-month and 12-month follow-up assessments

• Change from baseline in Epworth Sleepiness Scale (ESS) score

  Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS), with scores ranging from 0 to 24. Higher scores indicate greater daytime sleepiness. The secondary outcome is the change from baseline in ESS score.

  From baseline through 6-month and 12-month follow-up assessments

• Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score

  Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), with total scores ranging from 0 to 21. Higher scores indicate poorer sleep quality. The secondary outcome is the change from baseline in PSQI score.

  From baseline through 6-month and 12-month follow-up assessments

• Change from baseline in Hamilton Anxiety Rating Scale (HAMA) score

  Anxiety symptoms will be assessed using the Hamilton Anxiety Rating Scale (HAMA), with total scores ranging from 0 to 56. Higher scores indicate more severe anxiety. The secondary outcome is the change from baseline in HAMA score.

  From baseline through 6-month and 12-month follow-up assessments

• Change from baseline in Hamilton Depression Rating Scale-17 (HAMD-17) score

  Depressive symptoms will be assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17), with total scores ranging from 0 to 52. Higher scores indicate more severe depressive symptoms. The secondary outcome is the change from baseline in HAMD-17 score.

  From baseline through 6-month and 12-month follow-up assessments

• Change from baseline in Non-Motor Symptoms Scale (NMSS) total score

  Non-motor symptom burden will be assessed using the Non-Motor Symptoms Scale (NMSS), with total scores ranging from 0 to 360. Higher scores indicate greater severity of non-motor symptoms. The secondary outcome is the change from baseline in NMSS total score

  From baseline through 6-month and 12-month follow-up assessments

• Change from baseline in Montreal Cognitive Assessment (MoCA) score

  Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), with scores ranging from 0 to 30. Lower scores indicate worse cognitive performance. The secondary outcome is the change from baseline in MoCA score.

  From baseline through 6-month and 12-month follow-up assessments

Study Arms (2)

Parkinson's Disease Cohort

This cohort will include approximately 600 patients diagnosed with Parkinson's disease according to established Chinese diagnostic criteria. Participants will undergo standardized clinical assessments of motor and non-motor symptoms, neuroimaging (MRI, optional PET/SPECT), electrophysiological recordings, and collection of biospecimens (blood, saliva, optional CSF). Longitudinal follow-up will be conducted every 6 months to monitor disease progression and treatment response.

Multiple System Atrophy Cohort

This cohort will include approximately 100 patients with clinically diagnosed or probable multiple system atrophy, based on Chinese expert consensus criteria. Participants will undergo comprehensive clinical evaluation, neuroimaging, electrophysiological testing, and biospecimen collection (blood, saliva, optional CSF). Regular follow-up every 6 months will capture disease progression, functional decline, and potential biomarkers.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Yangzhi Rehabilitation Hospital: collaborator
• Shanghai Municipal Hospital of Traditional Chinese Medicine: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator
• Ruijin Hospital: lead
• Huashan Hospital: collaborator
• Longhua Hospital: collaborator

Study Sites (1)

Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The study will retain multiple types of biospecimens, including: Blood samples (whole blood, serum, plasma, DNA extraction) Saliva samples Cerebrospinal fluid (CSF) (optional, with patient consent)

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases

Central Study Contacts

Jun Liu, Professor

CONTACT

+86-021-64370045; lj11128@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: January 20, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)