Parkinsonian DisordersForPDCNNCT03649503
The National Registry Study For the Real-world Patients With Parkinsonian Disorders in China
An observational study of Parkinsonian Disorders, run by Huashan Hospital at 2 sites in China.
Trial summary
The overall goal of this project is to identify, assess and longitudinally monitor subjects who are interested in participating in this study. Participants will enroll through a platform named PaWei, and provide informed consent prior to any study activities. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinsonian Disorders
- How many people
- 100,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2018to 30 Sep 2033
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The Registry is a large, online database of volunteers who would like to participate in the research. Anyone with Parkinsonian Disorders is welcome to join the Registry.
Who may be able to join
- Anyone with Parkinsonian Disorders is welcome to join the Registry.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Guoying Cao, MD., 86-21-52888047, sherley_76@yahoo.com.cn
Feng-Tao Liu, MD., 86-21-52888163, liufengtao@fudan.edu.cn
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Jian Wang, MD., 86-21-52888160, wangjian336@hotmail.com
Feng-Tao Liu, MD., 86-21-52888163, liufengtao@fudan.edu.cn
About this study
Official title: The National Registry Study For the Real-world Patients With Parkinsonian Disorders in China (ForPDCN)
The overall goal of this project is to identify, assess and longitudinally monitor subjects who are interested in participating in this study. Participants will enroll through a platform named PaWei, and provide informed consent prior to any study activities. PaWei will collect a variety of information, including participants' demographic information, overall health, family history of Parkinson's Disease, other clinical information (clinical drug use, drug efficacy, and comorbid disorders), mood status, sleep, diet, exercise, memory complaints, online cognitive tests, the Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8), Movement Disorder Society-Unified Parkinson's Disease Rating Scale IB \& II (MDS-UPDRS IB \& II), Non-Motor Symptom Aassessment Scale for Parkinson's Disease (NMSS) , Hoehn and Yahr Scale, and other scales related to quality of life, etal---all through self-reported online questionnaires. Participants will also be asked to return to the PaWei every 3 months at regular intervals, to complete follow-up scales related to quality of life, and neuropsychological assessments, etal. Anyone with Parkinsonian Disorders is welcome to participate.
Read the detailed description
In April 2017, the investigators launched a platform named PaWei which contains an iOS and Android smartphone application for patients and doctors. The platform connects patients, doctors and researchers by establishing communication and data transfer between the cloud platform and the mobile applications over the internet. The PaWei app is made available for free to download through the Apple App Store and Android Market. Through national outpatient service, advertisement and community outreach, potential participants will be directed to the PaWei APP. The overall goal of this project is to identify, assess and longitudinally monitor subjects who are interested in participating in this study. Participants will enroll through the PaWei APP, and provide informed consent prior to any study activities.
The PaWei APP will include:
- Information about the National Registry Study (who is eligible to participate, the goals of the project and other relevant information about investigators and sponsors involved in the Initiative).
- Frequently Asked Questions (FAQs) such as "How will my information be used?", "How will patient information be safeguarded?", "What information will be requested?", "How much time will be required for registration and testing?" will be addressed for participants.
- General information about Parkinsonian Disorders.
The National Registry Study will be a large, online database of volunteers who are interested in participating in this study. Anyone with Parkinsonian Disorders is welcome to join the Registry.
- Participants will provide their email address or telephone number and create an account and username with the Registry.
- The Registry will send an automatic email or short message to the participant to verify their email address or telephone number.
- Participants will read the online Information Sheet and will be asked to provide their consent by clicking either "I consent" or "I decline." Participants who decline to participate in the Registry will be not included in our study.
- Participants who give their consent will be permitted to continue through the registration process, which includes completing a battery of questionnaires designed to obtain a general understanding of participants health, medical history wellbeing.
- In addition to questionnaires, participants will be able to complete online scales related to quality of life, and cognitive assessments.
- Participants will be given the option to elect a Caregiver and/or Study Partner (CASP) to enrich their study profile.
- Video recordings: Participants are asked to perform finger tapping, hand movements, and walking in MDS-UPDRS III test after being instructed by the video example, and then to upload the videos to the PaWei APP. The severity of motor dysfunctions on those videos can be judged by clinicians, and be potentially quantified in the future by AI technology under development.
- Data validation: (1) The quality control of raw data is the initial step of data analysis for any successful research. In PaWei platform, the investigators take a strategy of assessing the data quality by identifying poor-quality data, like incomplete data and illogical data based on the logistic verification about consistency of relevant questions. (2) Automated feedback loops are employed with this strategy to enable real-time detection of incomplete data or illogical data, which can be used to improve data collection quality.
- Participants may be referred to other research studies and/or clinical trials.
- Conditions
- Parkinsonian Disorders
- Being tested
- No intervention
- Keywords
- Brain Health, Brain Research, parkinsonism, prospective cohort study, large sample size
- Medical subject headings
- Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8) Score
The short-form 8-item Parkinson's disease Questionnaire (PDQ-8) is the most commonly used scale measuring health related quality of life (HRQoL) in PD patients. It includes 8 items, and each item has five options (never, occasionally, sometimes, often, always or cannot do at all). The total scores range from 0 (good health) to 32 (poor health). The change of PDQ-8 score is defined as the score collected at visit 4 (end of year 1), visit 8 (end of year 2), visit 12 (end of year 3), visit 16 (end of year 4), visit 20 (end of year 5), visit 24 (end of year 6), visit 28 (end of year 7), visit 32 (end of year 8), visit 36 (end of year 9), visit 40 (end of year 10), and final visit (last study visit or early withdrawal visit, up to 10 years) minus baseline score.
Analysis Method: Mixed Model Repeated Measures (MMRM)
Measured: Baseline, year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and final visit (last study visit or early withdrawal visit, up to 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Oct 2018
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsonian DisordersStudies of the same condition, open and under way.
- More trials run by Huashan 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
- 100,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Tianjin Medical University General Hospital, Peking Union Medical College Hospital, Chinese PLA General Hospital, Shanghai Zhongshan Hospital, The First Affiliated Hospital of the Fourth Military Medical University, Affiliated Hospital of North Sichuan Medical College, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Changshu Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Qingdao University, Guangxi Ruikang Hospital, Xi'an Central Hospital, First Affiliated Hospital of Chongqing Medical University, The First Hospital of Hebei Medical University, Jieyang People's Hospital, Luoyang Central Hospital, Taian City Central Hospital, Gansu Provincial Hospital, First Affiliated Hospital of Harbin Medical University, Daqing Oil Field Hospital, Fujian Provincial Hospital, The Affiliated Hospital of Xuzhou Medical University, Taizhou Hospital, Zhejiang Hospital, The 101st Hospital of Chinese People's Liberation Army, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Dalian Medical University, China-Japan Union Hospital, Jilin University, Wuhan No.1 Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Northern Jiangsu People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai 5th People's Hospital, Third People's Hospital, Huzhou City, Zhejiang Province, China, Suzhou Municipal Hospital, Ningbo No. 1 Hospital, The First People's Hospital of Changzhou, Affiliated Hospital of Jiangsu University, The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital with Nanjing Medical University, Fujian Medical University Union Hospital, Shanghai Changzheng Hospital, Second Affiliated Hospital of Nanchang University, Jingjiang People's Hospital, Qingdao Municipal Hospital, Xi'an No.3 Hospital, Lianyungang Hospital Affiliated Bengbu Medical College, Jinzhou Medical University, Shanghai 10th People's Hospital, Huadong Hospital, No. 102 Hospital of Chinese People's Liberation Army, Shandong Provincial Hospital, Anhui Provincial Hospital, Affiliated Hospital of Guangdong Medical University
- Responsible party
- Principal investigator, Jian Wang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649503
- Sponsor's protocol ID
- KY2016-214
- Acronym
- ForPDCN
- Status last verified
- Sep 2025
- First submitted
- 2 Aug 2018
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Registry Study For the Real-world Patients With Parkinsonian Disorders in China (ForPDCN)
- ClinicalTrials.gov ID
- NCT03649503
- Acronym / sponsor ID
- ForPDCN / KY2016-214
- Conditions
- Parkinsonian Disorders
- Keywords
- Brain Health, Brain Research, parkinsonism, prospective cohort study, large sample size
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Tianjin Medical University General Hospital, Peking Union Medical College Hospital, Chinese PLA General Hospital, Shanghai Zhongshan Hospital, The First Affiliated Hospital of the Fourth Military Medical University, Affiliated Hospital of North Sichuan Medical College, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Changshu Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Qingdao University, Guangxi Ruikang Hospital, Xi'an Central Hospital, First Affiliated Hospital of Chongqing Medical University, The First Hospital of Hebei Medical University, Jieyang People's Hospital, Luoyang Central Hospital, Taian City Central Hospital, Gansu Provincial Hospital, First Affiliated Hospital of Harbin Medical University, Daqing Oil Field Hospital, Fujian Provincial Hospital, The Affiliated Hospital of Xuzhou Medical University, Taizhou Hospital, Zhejiang Hospital, The 101st Hospital of Chinese People's Liberation Army, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Dalian Medical University, China-Japan Union Hospital, Jilin University, Wuhan No.1 Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Northern Jiangsu People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai 5th People's Hospital, Third People's Hospital, Huzhou City, Zhejiang Province, China, Suzhou Municipal Hospital, Ningbo No. 1 Hospital, The First People's Hospital of Changzhou, Affiliated Hospital of Jiangsu University, The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital with Nanjing Medical University, Fujian Medical University Union Hospital, Shanghai Changzheng Hospital, Second Affiliated Hospital of Nanchang University, Jingjiang People's Hospital, Qingdao Municipal Hospital, Xi'an No.3 Hospital, Lianyungang Hospital Affiliated Bengbu Medical College, Jinzhou Medical University, Shanghai 10th People's Hospital, Huadong Hospital, No. 102 Hospital of Chinese People's Liberation Army, Shandong Provincial Hospital, Anhui Provincial Hospital, Affiliated Hospital of Guangdong Medical University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2033 (estimated)
- First posted
- 28 Aug 2018 (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.
The overall goal of this project is to identify, assess and longitudinally monitor subjects who are interested in participating in this study. Participants will enroll through a platform named PaWei, and provide informed consent prior to any study activities. PaWei will collect a variety of information, including participants' demographic information, overall health, family history of Parkinson's Disease, other clinical information (clinical drug use, drug efficacy, and comorbid disorders), mood status, sleep, diet, exercise, memory complaints, online cognitive tests, the Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8), Movement Disorder Society-Unified Parkinson's Disease Rating Scale IB \& II (MDS-UPDRS IB \& II), Non-Motor Symptom Aassessment Scale for Parkinson's Disease (NMSS) , Hoehn and Yahr Scale, and other scales related to quality of life, etal---all through self-reported online questionnaires. Participants will also be asked to return to the PaWei every 3 months at regular intervals, to complete follow-up scales related to quality of life, and neuropsychological assessments, etal. Anyone with Parkinsonian Disorders is welcome to participate.
Detailed description
In April 2017, the investigators launched a platform named PaWei which contains an iOS and Android smartphone application for patients and doctors. The platform connects patients, doctors and researchers by establishing communication and data transfer between the cloud platform and the mobile applications over the internet. The PaWei app is made available for free to download through the Apple App Store and Android Market. Through national outpatient service, advertisement and community outreach, potential participants will be directed to the PaWei APP. The overall goal of this project is to identify, assess and longitudinally monitor subjects who are interested in participating in this study. Participants will enroll through the PaWei APP, and provide informed consent prior to any study activities.
The PaWei APP will include:
- Information about the National Registry Study (who is eligible to participate, the goals of the project and other relevant information about investigators and sponsors involved in the Initiative).
- Frequently Asked Questions (FAQs) such as "How will my information be used?", "How will patient information be safeguarded?", "What information will be requested?", "How much time will be required for registration and testing?" will be addressed for participants.
- General information about Parkinsonian Disorders.
The National Registry Study will be a large, online database of volunteers who are interested in participating in this study. Anyone with Parkinsonian Disorders is welcome to join the Registry.
- Participants will provide their email address or telephone number and create an account and username with the Registry.
- The Registry will send an automatic email or short message to the participant to verify their email address or telephone number.
- Participants will read the online Information Sheet and will be asked to provide their consent by clicking either "I consent" or "I decline." Participants who decline to participate in the Registry will be not included in our study.
- Participants who give their consent will be permitted to continue through the registration process, which includes completing a battery of questionnaires designed to obtain a general understanding of participants health, medical history wellbeing.
- In addition to questionnaires, participants will be able to complete online scales related to quality of life, and cognitive assessments.
- Participants will be given the option to elect a Caregiver and/or Study Partner (CASP) to enrich their study profile.
- Video recordings: Participants are asked to perform finger tapping, hand movements, and walking in MDS-UPDRS III test after being instructed by the video example, and then to upload the videos to the PaWei APP. The severity of motor dysfunctions on those videos can be judged by clinicians, and be potentially quantified in the future by AI technology under development.
- Data validation: (1) The quality control of raw data is the initial step of data analysis for any successful research. In PaWei platform, the investigators take a strategy of assessing the data quality by identifying poor-quality data, like incomplete data and illogical data based on the logistic verification about consistency of relevant questions. (2) Automated feedback loops are employed with this strategy to enable real-time detection of incomplete data or illogical data, which can be used to improve data collection quality.
- Participants may be referred to other research studies and/or clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Registry is a large, online database of volunteers who would like to participate in the research. Anyone with Parkinsonian Disorders is welcome to join the Registry.
Key inclusion criteria (1 listed)
- Anyone with Parkinsonian Disorders is welcome to join the Registry.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | – |
Primary outcome
Change from Baseline in the Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8) Score
Time frame: Baseline, year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and final visit (last study visit or early withdrawal visit, up to 10 years)
The short-form 8-item Parkinson's disease Questionnaire (PDQ-8) is the most commonly used scale measuring health related quality of life (HRQoL) in PD patients. It includes 8 items, and each item has five options (never, occasionally, sometimes, often, always or cannot do at all). The total scores range from 0 (good health) to 32 (poor health). The change of PDQ-8 score is defined as the score collected at visit 4 (end of year 1), visit 8 (end of year 2), visit 12 (end of year 3), visit 16 (end of year 4), visit 20 (end of year 5), visit 24 (end of year 6), visit 28 (end of year 7), visit 32 (end of year 8), visit 36 (end of year 9), visit 40 (end of year 10), and final visit (last study visit or early withdrawal visit, up to 10 years) minus baseline score. Analysis Method: Mixed Model Repeated Measures (MMRM)
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 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinsonian Disorders, run by Huashan Hospital at 2 sites 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 1 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jian Wang, MD (86-21-52888160, wangjian336@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8) Score (time frame: Baseline, year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and final visit (last study visit or early withdrawal visit, up to 10 years)). 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 2 Oct 2025.