Parkinson's Disease (PD)NCT07353463
Shanghai Clinical Cohort - Parkinson's Disease (Reserve)
An observational study of Parkinson's Disease (PD) and Multiple System Atrophy, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease (PD), Multiple System Atrophy
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Jun Liu, Professor, +86-021-64370045, lj11128@rjh.com.cn
About this study
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:
Read more
- 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
- Parkinson's Disease (PD), Multiple System Atrophy
- Keywords
- observational cohort study, multimodal data, subtyping, long-term monitoring
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: From baseline through 6-month and 12-month follow-up assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital, Shanghai Sunshine Rehabilitation Center, Longhua Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353463
- Sponsor's protocol ID
- Parkinson's Disease Cohort
- Other IDs
- SHDC2025CCS043
- Status last verified
- Apr 2025
- First submitted
- 13 Nov 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Clinical Cohort - Parkinson's Disease (Reserve)
- ClinicalTrials.gov ID
- NCT07353463
- Acronym / sponsor ID
- Parkinson's Disease Cohort
- Conditions
- Parkinson's Disease (PD), Multiple System Atrophy
- Keywords
- observational cohort study, multimodal data, subtyping, long-term monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Huashan Hospital, Shanghai Sunshine Rehabilitation Center, Longhua Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
Key exclusion criteria (7 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease (PD) and Multiple System Atrophy, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Liu, Professor (+86-021-64370045, lj11128@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.