跳至主要内容
临床试验/NCT07588763
NCT07588763尚未招募不适用

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

Fujian Medical University Union Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2026年4月28日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
3,000
试验地点
1
主要终点
5-Year and 10-Year Survival Rates and Prognostic Factors in Idiopathic Parkinson's Disease Patients in Southeast China

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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.

结局指标

主要结局

5-Year and 10-Year Survival Rates and Prognostic Factors in Idiopathic Parkinson's Disease Patients in Southeast China

时间窗: 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

时间窗: 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.

次要结局

  • Identification of Multimodal Biomarkers for Early Diagnosis and Disease Progression in Parkinson's Disease(Baseline, every 12 months during the 10-year follow-up period)
  • Genetic Profiling of Patients with Idiopathic Parkinson's Disease in Southeast China(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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