Chinese PD-SNCA Registry

Parkinson Disease Clinical Trial

Official title:

The Chinese Parkinson's Disease With SNCA Variants Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03523052
• Other study ID #: CPD-SNCAR
• 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 PD-SNCA Registry(CPD-SNCAR) is to develop a database of patients of Parkinson's disease with a-synuclein (SNCA) gene variants in mainland China.

Description:

Parkinson's disease (PD) is the second most common disorder among neurodegenerative diseases. SNCA is the first gene implicated in monogenic parkinsonism. However, some polymorphisms of SNCA gene such as rs894278 and rs11931074 can affect the risk of sporadic PD. The investigators aim to establish a database of PD with SNCA variants and characterize the clinical manifestation of these patients in mainland China.

Method:

1. Peripheral blood from patients has been tested to have SNCA 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: 3000
• 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 positive SNCA 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 (4)

Ai SX, Xu Q, Hu YC, Song CY, Guo JF, Shen L, Wang CR, Yu RL, Yan XX, Tang BS. Hypomethylation of SNCA in blood of patients with sporadic Parkinson's disease. J Neurol Sci. 2014 Feb 15;337(1-2):123-8. doi: 10.1016/j.jns.2013.11.033. Epub 2013 Dec 1. — 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

Hu Y, Tang B, Guo J, Wu X, Sun Q, Shi C, Hu L, Wang C, Wang L, Tan L, Shen L, Yan X, Zhang H. Variant in the 3' region of SNCA associated with Parkinson's disease and serum a-synuclein levels. J Neurol. 2012 Mar;259(3):497-504. doi: 10.1007/s00415-011-620 — View Citation

Wei Y, Yang N, Xu Q, Sun Q, Guo J, Li K, Liu Z, Yan X, Zhu X, Tang B. The rs3756063 polymorphism is associated with SNCA methylation in the Chinese Han population. J Neurol Sci. 2016 Aug 15;367:11-4. doi: 10.1016/j.jns.2016.05.037. Epub 2016 May 19. — View Citation

Outcome

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