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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFujian Medical University Union Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

3,000 Participants
are grouped into 1 trial group
Group A: Idiopathic Parkinson's Disease (PD) Patients

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years and 10 years after study enrollment
2

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.

Time frame
Baseline and every 6 months during the 10-year follow-up period

Secondary outcomes

1

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.

Time frame
Baseline, every 12 months during the 10-year follow-up period
2

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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