Shanghai Clinical Cohort - Parkinson's Disease (Reserve)

Condition(s) studied

Study 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

Eligibility

Primary outcome measure(s)

• Change from baseline in motor symptom severity assessed by MDS-UPDRS Part III — 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.
• Change from baseline in Hoehn & Yahr stage — 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.
• Change from baseline in Brief Pain Inventory (BPI) pain severity score — 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.
• Change from baseline in REM Sleep Behavior Disorder Questionnaire-Hong Kong (RBDQ-HK) score — 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.
• Change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLSS) score — 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.
• Change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score — 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.
• Change from baseline in Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT) score — 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.
• Change from baseline in Epworth Sleepiness Scale (ESS) score — 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.
• Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score — 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.
• Change from baseline in Hamilton Anxiety Rating Scale (HAMA) score — 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.
• Change from baseline in Hamilton Depression Rating Scale-17 (HAMD-17) score — 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.
• Change from baseline in Non-Motor Symptoms Scale (NMSS) total score — 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
• Change from baseline in Montreal Cognitive Assessment (MoCA) score — 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.

Trial sites (1)

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