Parkinson Disease (PD)NCT07588763
A Multimodal Convergent Cohort of Parkinson's Disease at FJMUUH (FJMUUH-PD): Natural History Study
An observational study of Parkinson Disease (PD), run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease (PD)
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2026to 31 Dec 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fujian Medical University Union Hospital, Department of Neurology
Fujian, Fuzhou, 350000
ye qinyong, MD, 13365910205, uniongyye@163.com
About this 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.
- Conditions
- Parkinson Disease (PD)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and every 6 months during the 10-year follow-up period
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start28 Apr 2026 (estimated)
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588763
- Sponsor's protocol ID
- 2026KY548
- Status last verified
- Jan 2026
- First submitted
- 9 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Convergent Cohort of Parkinson's Disease at FJMUUH (FJMUUH-PD): Natural History Study
- ClinicalTrials.gov ID
- NCT07588763
- Acronym / sponsor ID
- 2026KY548
- Conditions
- Parkinson Disease (PD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 28 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
5-Year and 10-Year Survival Rates and Prognostic Factors in Idiopathic Parkinson's Disease Patients in Southeast China
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.
Longitudinal Disease Progression and Associated Factors in Idiopathic Parkinson's Disease Patients in Southeast China
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.
2 secondary outcomes
Identification of Multimodal Biomarkers for Early Diagnosis and Disease Progression in Parkinson's Disease
Time frame: Baseline, every 12 months during the 10-year follow-up period
Genetic Profiling of Patients with Idiopathic Parkinson's Disease in Southeast China
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease (PD), run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ye qinyong, MD (13365910205, uniongyye@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-Year and 10-Year Survival Rates and Prognostic Factors in Idiopathic Parkinson's Disease Patients in Southeast China (time frame: 5 years and 10 years after study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.