A Multimodal Convergent Cohort of Parkinson's Disease at FJMUUH (FJMUUH-PD): Natural History Study

Parkinson's disease (PD) is a common neurodegenerative disorder in middle-aged and elderly individuals, with a global incidence of 2.0% among adults aged 65 and over. Its pathogenesis remains unclear, and effective preventive and therapeutic approaches are lacking. PD severely impairs patients' physical and mental health and quality of life, while also imposing a substantial burden on families and society. This study will enroll patients with idiopathic PD diagnosed in the Department of Neurology, Fujian Medical University Union Hospital, from 2026 to 2036 to establish a research cohort. Using a non-interventional design, participants will undergo long-term follow-up through regular clinical visits, scale-based assessments, imaging examinations, and biological specimen testing. Corresponding data will be collected to build a research platform, aiming to clarify the pattern of disease progression and identify early diagnostic biomarkers. All testing methods are safe and reliable and will not pose additional risks to patients.

This study will be conducted in strict compliance with ethical requirements. Prior to enrollment, patients will be fully informed of the study details and will voluntarily provide written informed consent. To mitigate the risk of privacy disclosure, measures including coded management, data encryption, and access restriction will be implemented throughout the study to protect participants' privacy, safeguard their legitimate rights and interests, avoid additional financial burdens, and ensure the study is conducted in a standardized manner.

I hereby pledge to protect the personal privacy of all study participants and respect their autonomy. The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Ethical Review Measures for Life Sciences and Medical Research Involving Human Subjects.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease (PD)

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: ye qinyong, MD; Phone Number: 13365910205; Email: uniongyye@163.com

Study Locations

• China
  • Fuzhou
    • Fujian, Fuzhou, China, 350000
      • Fujian Medical University Union Hospital, Department of Neurology
      • Contact: ye qinyong, MD; Phone Number: 13365910205; Email: uniongyye@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with idiopathic Parkinson's disease (PD) diagnosed at the Department of Neurology, Fujian Medical University Union Hospital in Southeast China, according to the 2016 Chinese PD Diagnostic Criteria. Eligible patients will be consecutively enrolled during the study period (2026-2035) and followed up prospectively for up to 10 years.

Description

Inclusion Criteria:

• The diagnosis of Parkinson's disease (PD) will be made according to the Chinese Diagnostic Criteria for Parkinson's Disease (2016) issued by the Parkinson's Disease and Movement Disorders Group of the Neurology Branch of the Chinese Medical Association, with confirmation by at least two neurologists. Eligible patients must meet all of the following criteria:

Definite diagnosis of parkinsonism; No absolute exclusion criteria for PD are present; At least 2 supportive criteria for PD are satisfied; No red flags suggestive of alternative diagnoses are present.

Exclusion Criteria:

• Patients meeting any of the following conditions will be excluded from the study:

Inability to complete assessments using the Unified Parkinson Disease Rating Scale (UPDRS); Inability to complete assessments using the Mini-Mental State Examination (MMSE); History of recurrent stroke causing stepwise deterioration of parkinsonian symptoms; Diagnosis of secondary parkinsonism or Parkinson-plus syndromes; History of recurrent head trauma or confirmed encephalitis; Presence of severe organ dysfunction; Presence of severe endocrine diseases; Presence of hematological disorders; Presence of autoimmune diseases; Current diagnosis of malignant tumors.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Idiopathic Parkinson's Disease (PD) Patients; This cohort includes patients diagnosed with idiopathic Parkinson's disease (PD) at the Department of Neurology, Fujian Medical University Union Hospital. This is a non-interventional, prospective observational study. Participants will undergo regular clinical visits, standardized scale assessments, imaging examinations, and biological sample collection for long-term follow-up. No additional investigational interventions will be performed beyond routine clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-Year and 10-Year Survival Rates and Prognostic Factors in Idiopathic Parkinson's Disease Patients in Southeast China	To estimate the 5-year and 10-year overall survival rates among patients with idiopathic Parkinson's disease in Southeast China, and to analyze the impact of clinical, genetic, and lifestyle factors on survival outcomes.	5 years and 10 years after study enrollment
Longitudinal Disease Progression and Associated Factors in Idiopathic Parkinson's Disease Patients in Southeast China	To characterize the longitudinal progression of idiopathic Parkinson's disease (PD) in patients from Southeast China, and to identify clinical, demographic, and biological factors associated with disease progression, using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III and Hoehn & Yahr staging as primary measures.	Baseline and every 6 months during the 10-year follow-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of Multimodal Biomarkers for Early Diagnosis and Disease Progression in Parkinson's Disease	To identify and validate multimodal biomarkers (including exosomal proteins, neuroimaging features, and clinical scale scores) for early diagnosis of Parkinson's disease, and to evaluate their utility as objective measures for monitoring disease progression and guiding future clinical trials.	Baseline, every 12 months during the 10-year follow-up period
Genetic Profiling of Patients with Idiopathic Parkinson's Disease in Southeast China	To characterize the genotypic profile of patients with idiopathic Parkinson's disease in Southeast China, including analysis of common PD-associated genetic variants, and to explore their associations with clinical phenotypes and disease progression.	Baseline

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 28, 2026
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: May 9, 2026
• First Submitted That Met QC Criteria: May 9, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 2026KY548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No