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Chinese PD-GBA Registry

Sponsor
Xiangya Hospital of Central South University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03523065
Collaborator
(none)
500
Enrollment
1
Location
120
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Chinese Parkinson's Disease With GBA Variants Registry
    Actual Study Start Date :
    Feb 1, 2017
    Anticipated Primary Completion Date :
    Feb 1, 2027
    Anticipated Study Completion Date :
    Feb 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Database of Parkinson's disease with GBA variants [10 years]

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

    2. Clinical feature [10 years]

      Characterize the clinical feature of PD patients with GBA variants

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xiangya Hospital of Central South University Changsha Hunan China 410008

    Sponsors and Collaborators

    • Xiangya Hospital of Central South University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Xiangya Hospital of Central South University
    ClinicalTrials.gov Identifier:
    NCT03523065
    Other Study ID Numbers:
    • CPD-GBAR
    First Posted:
    May 14, 2018
    Last Update Posted:
    May 29, 2018
    Last Verified:
    Apr 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of May 29, 2018