NCT03649503

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
90mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Oct 2018Sep 2033

First Submitted

Initial submission to the registry

August 2, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2033

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

10 years

First QC Date

August 2, 2018

Last Update Submit

September 29, 2025

Conditions

Parkinsonian Disorders

Keywords

Brain HealthBrain Researchparkinsonismprospective cohort studylarge sample size

Outcome Measures

Primary Outcomes (1)

  • 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)

    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)

Interventions

No interventionOTHER

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Anyone with Parkinsonian Disorders is welcome to join the Registry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement Disorders

Central Study Contacts

Jian Wang, MD

CONTACT

86-21-52888160wangjian336@hotmail.com

cuiyun wu, master

CONTACT

86-21-52888047wucuiyun@fudan.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Deputy Director, Department of Neurology

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 28, 2018

Study Start

October 1, 2018

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2033

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations

CN(2)