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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03508960
Other study ID # CEOPDR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date February 1, 2027

Study information

Verified date April 2018
Source Xiangya Hospital of Central South University
Contact J Guo, Ph.D.
Phone +8613974936815
Email guojifeng2003@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the Chinese Early-onst Parkinson's disease Registry (CEOPDR) is to develop a database of persons with early-onset Parkinson's disease (EOPD) in China.


Description:

Parkinson's disease (PD) is the second most common disorder among degenerative neurological disease. Early-onset PD (EOPD) has its unique clinical feature and genetic basis.Investigators aim to establish a database of EOPD,and characterize the clinical feature, genetic basis, environmental factors and their interactions EOPD in China.

Method:

1. Clinical feature will be measured by scales and neurological tests.Standard scales includes: Unified Parkinson's Disease Rating Scale(UPDRS), Hoehn-Yahr stages, NMSS, MMSE, PDSS(Parkinson disease sleep scales),Rapid Eye Movement Sleep Behaviour Disorder Questionnaire(RBDQ-HK),ESS(Epworth Sleepiness Scale),Rome III functional constipation scale,SCOPA-AUT (the Scale for Outcomes in PD for Autonomic Symptoms),PFS(Parkinson Fatigue Scale),CH-RLSq,Hyposmia rating scale(HRS)HAMILT depression scale,the 39-item Parkinson's Disease Questionnaire(PDQ-39),Freezing of gait scale(FOG),dyskinesia related scales, Wearing-off scale(WO)

2. Peripheral blood from patients was collected for whole exome sequencing.

3. The environmental factors are explored by questionnaires including smoking,drinking, pesticide and heavy metals.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date February 1, 2027
Est. primary completion date February 1, 2027
Accepts healthy volunteers No
Gender All
Age group N/A to 50 Years
Eligibility Inclusion Criteria:

- Patients diagnosed with PD by UKBB and other standard criteria Age of onset is no more than 50 years old.

Exclusion Criteria:

- Patients have a family history of PD.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Xiangya Hospital of Central South University Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (5)

Fan K, Tang BS, Wang YQ, Kang JF, Li K, Liu ZH, Sun QY, Xu Q, Yan XX, Guo JF. The GBA, DYRK1A and MS4A6A polymorphisms influence the age at onset of Chinese Parkinson patients. Neurosci Lett. 2016 May 16;621:133-136. doi: 10.1016/j.neulet.2016.04.014. Epu — View Citation

Li K, Tang BS, Liu ZH, Kang JF, Zhang Y, Shen L, Li N, Yan XX, Xia K, Guo JF. LRRK2 A419V variant is a risk factor for Parkinson's disease in Asian population. Neurobiol Aging. 2015 Oct;36(10):2908.e11-5. doi: 10.1016/j.neurobiolaging.2015.07.012. Epub 2015 Jul 11. — View Citation

Liu Z, Tang B, Guo J, Zhou X, Sun Q, Xu Q, Xu C, Yan X. Mutations analysis of RAB39B gene in Chinese early-onset Parkinson's disease. Parkinsonism Relat Disord. 2016 Jul;28:157-8. doi: 10.1016/j.parkreldis.2016.03.019. Epub 2016 Mar 24. — View Citation

Liu ZH, Guo JF, Li K, Wang YQ, Kang JF, Wei Y, Sun QY, Xu Q, Wang DL, Xia K, Yan XX, Xu CS, Tang BS. Analysis of several loci from genome-wide association studies in Parkinson's disease in mainland China. Neurosci Lett. 2015 Feb 5;587:68-71. doi: 10.1016/j.neulet.2014.12.027. Epub 2014 Dec 17. — View Citation

Yang Y, Tang BS, Weng L, Li N, Shen L, Wang J, Zuo CT, Yan XX, Xia K, Guo JF. Genetic Identification Is Critical for the Diagnosis of Parkinsonism: A Chinese Pedigree with Early Onset of Parkinsonism. PLoS One. 2015 Aug 21;10(8):e0136245. doi: 10.1371/journal.pone.0136245. eCollection 2015. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Database of Early-onset Parkinson's Disease To collect 3000 patients with early-onset parkinson's disease and establish the database of early-onset Parkinson's disease in mainland China. 10 years
Primary Risk Factors To characterize clinical feature and environmental factors among Chinese early-onset parkinson's disease 10 years
Primary Genetic Basis To characterize the genetic basis of Chinese EOPD and detect clinically relevant genetic variants in these cases. 10 years
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