Shanghai Clinical Cohort - Parkinson's Disease (Reserve)
Recruiting · NCT07353463 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ruijin Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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
Who can take part
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.
Where it is running
1 location listed.
- Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine - Shanghai, China