Fujian Medical University Union Hospital, Department of Neurology
Fujian, Fuzhou, 350000, China
NCT Number: NCT07588763
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.
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Observational
Fujian, Fuzhou, 350000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion 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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, every 12 months during the 10-year follow-up period
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.
Time frame: Baseline
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.
Contact information is provided by the study sponsor or research team.
Fujian Medical University Union Hospital
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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