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NCT Number: NCT07353463

Shanghai Clinical Cohort - Parkinson's Disease (Reserve)

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

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Key information

Conditions

Parkinson's Disease (PD) Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Multiple System Atrophy Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Primary Dysautonomias Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, 200025, China

Location status: Recruiting

Location contact

Jun Liu, Professor

CONTACT

[email protected]

+86-021-64370045

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

    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.

  2. Change from baseline in Hoehn & Yahr stage

    Time frame: From baseline through 6-month and 12-month follow-up assessments

    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.

  3. Change from baseline in Brief Pain Inventory (BPI) pain severity score

    Time frame: From baseline through 6-month and 12-month follow-up assessments

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. 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

    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.

  8. Change from baseline in Epworth Sleepiness Scale (ESS) score

    Time frame: From baseline through 6-month and 12-month follow-up assessments

    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.

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

    Time frame: From baseline through 6-month and 12-month follow-up assessments

    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.

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

    Time frame: From baseline through 6-month and 12-month follow-up assessments

    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.

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

    Time frame: From baseline through 6-month and 12-month follow-up assessments

    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.

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

    Time frame: From baseline through 6-month and 12-month follow-up assessments

    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

  13. Change from baseline in Montreal Cognitive Assessment (MoCA) score

    Time frame: From baseline through 6-month and 12-month follow-up assessments

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Liu, Professor

CONTACT

[email protected]

+86-021-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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