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NCT Number: NCT03523104

Chinese PD-LRRK2 Registry

The purpose of the Chinese PD-LRRK2 Registry(CPD-LRRK2R) is to develop a database of patients of Parkinson's disease with leucine-rich repeat kinase 2 (LRRK2) gene variants in mainland China.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Parkinson's disease (PD) is the second most common disorder among neurodegenerative diseases. LRRK2 missense mutations are the most common known genetic cause of PD. However, some polymorphisms of LRRK2 such as G2385R and R1628P can also affect the risk of developing PD. The investigators aim to establish a database of PD with LRRK2 variants and characterize the clinical manifestation of these patients in mainland China.

Method:

  • Peripheral blood from patients has been tested to have LRRK2 gene variants.
  • 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).
  • The investigators will also exam the blood biomarkers of PD such as uric acid and peripheral inflammatory markers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 LRRK2 variants

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Database of Parkinson's disease with LRRK2 variants

    Time frame: 10 years

    Establish the database of Parkinson's disease with LRRK2 variants in mainland China.

  2. Clinical feature

    Time frame: 10 years

    Characterize the clinical feature in patients of Parkinson's disease with LRRK2 variants

Study contacts

Contact information is provided by the study sponsor or research team.

Beisha Tang, Ph.D.

CONTACT

[email protected]

+8613974856709

Jifeng Guo, Ph.D.

CONTACT

[email protected]

+8613974936815

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study title

The Chinese Parkinson's Disease With LRRK2 Variants Registry

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
May 14, 2018
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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