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

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• 5-Year and 10-Year Survival Rates and Prognostic Factors in Idiopathic Parkinson's Disease Patients in Southeast China — 5 years and 10 years after study enrollment
  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.
• Longitudinal Disease Progression and Associated Factors in Idiopathic Parkinson's Disease Patients in Southeast China — Baseline and every 6 months during the 10-year follow-up period
  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.

Trial sites (1)

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