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RecruitingNCT03523065Updated May 29, 2018

Chinese PD-GBA Registry

An observational study in Parkinson Disease, sponsored by Xiangya Hospital of Central South University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2018-05-29.

Sponsored by Xiangya Hospital of Central South University · Observational

From the registry’s dates

  • Started Feb 2017; still recruiting 9 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Sex
All
01

Study 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.

Read the detailed 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.
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Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 500 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Xiangya Hospital of Central South University is the lead sponsor of 170 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

PD patients with GBA gene variants

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

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Database of Parkinson's disease with GBA variants

    Establish the database of Parkinson's disease with GBA variants in mainland China.

    Time frame: 10 years

  2. Clinical feature

    Characterize the clinical feature of PD patients with GBA variants

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Xiangya Hospital of Central South University
    Changsha, Hunan 410008, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 29527153 ↗
  • 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. PubMed 20131388 ↗
  • 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.neurobiolaging.2014.12.030. Epub 2015 Jan 6. PubMed 25623333 ↗
  • 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. PubMed 26421210 ↗
  • 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. Epub 2016 Apr 13. PubMed 27085534 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03523065
Lead sponsor
Xiangya Hospital of Central South University
Responsible party
Sponsor
First posted
May 14, 2018
Start date
Feb 1, 2017
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
May 29, 2018

Study contacts

Jifeng Guo, Ph.D.
Contact
guojifeng2003@163.com
+8613974936815
Beisha Tang, Ph.D.
Contact
bstang7398@163.com
+8613974856709

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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