Chinese PD-GBA Registry

Parkinson Disease Clinical Trial

Official title:

The Chinese Parkinson's Disease With GBA Variants Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03523065
• Other study ID #: CPD-GBAR
• Status: Recruiting
• 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: Jifeng Guo, Ph.D.
• Phone: +8613974936815
• Email: guojifeng2003[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the Chinese Parkinson's disease with GBA variants Registry (CPD-GBAR) is to develop a database of patients of Parkinson's disease with Glucocerebrosidase (GBA) gene variants in mainland China.

Description:

Parkinson's disease (PD) is the second most common disorder among neurodegenerative diseases. GBA gene variants such as L444P can influence the risk of developing PD and these variants have the greatest impact on PD susceptibility among all the PD related gene variants yet discovered. The investigators aim to establish a database of PD with GBA variants and characterize the clinical manifestation of these patients in mainland China.

Method:

1. Peripheral blood from patients has been tested to have GBA gene variants.

2. Clinical manifestation will be measured by scales and neurological tests. Standard scales include: Unified Parkinson's Disease Rating Scale(UPDRS), Hoehn-Yahr stages, Non-Motor Symptoms Scale (NMSS), mini-mental state examination (MMSE), Parkinson disease sleep scales (PDSS), Rapid Eye Movement Sleep Behaviour Disorder Questionnaire(RBDQ-HK), Epworth Sleepiness Scale (ESS), Rome III functional constipation scale, the Scale for Outcomes in PD for Autonomic Symptoms (SCOPA-AUT), Parkinson Fatigue Scale (PFS), Cambridge-Hopkins Restless Legs Syndrome questionnaire (CHRLSq), Hyposmia rating scale(HRS), Hamilton depression scale, the 39-item Parkinson's Disease Questionnaire(PDQ-39), Freezing of gait scale(FOG), dyskinesia related scales, Wearing-off scale(WO).

3. The investigators will also exam the blood biomarkers of PD such as uric acid and peripheral inflammatory markers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with PD by the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria or other standard criteria; PD patients detected with GBA gene variants.

Exclusion Criteria:

Related Conditions & MeSH terms

• Parkinson Disease

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

Guo JF, Li K, Yu RL, Sun QY, Wang L, Yao LY, Hu YC, Lv ZY, Luo LZ, Shen L, Jiang H, Yan XX, Pan Q, Xia K, Tang BS. Polygenic determinants of Parkinson's disease in a Chinese population. Neurobiol Aging. 2015 Apr;36(4):1765.e1-1765.e6. doi: 10.1016/j.neuro — View Citation

Sun QY, Guo JF, Wang L, Yu RH, Zuo X, Yao LY, Pan Q, Xia K, Tang BS. Glucocerebrosidase gene L444P mutation is a risk factor for Parkinson's disease in Chinese population. Mov Disord. 2010 Jun 15;25(8):1005-11. doi: 10.1002/mds.23009. — View Citation

Zhang Y, Shu L, Sun Q, Zhou X, Pan H, Guo J, Tang B. Integrated Genetic Analysis of Racial Differences of Common GBA Variants in Parkinson's Disease: A Meta-Analysis. Front Mol Neurosci. 2018 Feb 15;11:43. doi: 10.3389/fnmol.2018.00043. eCollection 2018. — View Citation

Zhang Y, Sun QY, Zhao YW, Shu L, Guo JF, Xu Q, Yan XX, Tang BS. Effect of GBA Mutations on Phenotype of Parkinson's Disease: A Study on Chinese Population and a Meta-Analysis. Parkinsons Dis. 2015;2015:916971. doi: 10.1155/2015/916971. Epub 2015 Sep 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Database of Parkinson's disease with GBA variants	Establish the database of Parkinson's disease with GBA variants in mainland China.	10 years
Primary	Clinical feature	Characterize the clinical feature of PD patients with GBA variants	10 years