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Chinese PD-SNCA Registry

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ClinicalTrials.gov Identifier: NCT03523052
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief 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.

Condition or disease
Parkinson Disease

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Chinese Parkinson's Disease With SNCA Variants Registry
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 1, 2027
Estimated Study Completion Date : February 1, 2027

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Database of Parkinson's disease with SNCA variants [ Time Frame: 10 years ]
    Establish the database of Parkinson's disease with SNCA variants in mainland China.

  2. Clinical feature [ Time Frame: 10 years ]
    Characterize the clinical feature in patients of Parkinson's disease with SNCA variants



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PD patients with SNCA variants
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523052


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

Locations
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China, Hunan
Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Jifeng Guo, Ph.D.    +8613974936815    guojifeng2003@163.com   
Contact: Qiying Sun, Ph.D.    +8615874907260    sunqiying2015@163.com   
Sponsors and Collaborators
Xiangya Hospital of Central South University
Publications of Results:
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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03523052    
Other Study ID Numbers: CPD-SNCAR
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases