Chinese PD-LRRK2 Registry

NCT ID: NCT03523104

Last Updated: 2018-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2027-02-01

Brief Summary

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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.

Detailed Description

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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:

1. Peripheral blood from patients has been tested to have LRRK2 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.

Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jifeng Guo, Ph.D.

Role: CONTACT

+8613974936815

Beisha Tang, Ph.D.

Role: CONTACT

+8613974856709

Facility Contacts

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Jifeng Guo, Ph.D.

Role: primary

+8613974936815

Qiying Sun, Ph.D.

Role: backup

+8615874907260

References

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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.

Reference Type RESULT
PMID: 25623333 (View on PubMed)

Li K, Tang BS, Liu ZH, Kang JF, Zhang Y, Shen L, Li N, Yan XX, Xia K, Guo JF. LRRK2 A419V variant is a risk factor for Parkinson's disease in Asian population. Neurobiol Aging. 2015 Oct;36(10):2908.e11-5. doi: 10.1016/j.neurobiolaging.2015.07.012. Epub 2015 Jul 11.

Reference Type RESULT
PMID: 26234753 (View on PubMed)

Yao LY, Guo JF, Wang L, Yu RH, Sun QY, Pan Q, Xia K, Tang BS, Shen L. LRRK2 Pro755Leu variant in ethnic Chinese population with Parkinson's disease. Neurosci Lett. 2011 May 9;495(1):35-8. doi: 10.1016/j.neulet.2011.03.030. Epub 2011 Mar 22.

Reference Type RESULT
PMID: 21406209 (View on PubMed)

Wang L, Guo JF, Nie LL, Xu Q, Zuo X, Sun QY, Yan XX, Tang BS. A novel LRRK2 mutation in a mainland Chinese patient with familial Parkinson's disease. Neurosci Lett. 2010 Jan 14;468(3):198-201. doi: 10.1016/j.neulet.2009.10.080. Epub 2009 Oct 29.

Reference Type RESULT
PMID: 19879329 (View on PubMed)

Zhang Y, Sun Q, Yi M, Zhou X, Guo J, Xu Q, Tang B, Yan X. Genetic Analysis of LRRK2 R1628P in Parkinson's Disease in Asian Populations. Parkinsons Dis. 2017;2017:8093124. doi: 10.1155/2017/8093124. Epub 2017 Oct 25.

Reference Type RESULT
PMID: 29209554 (View on PubMed)

Other Identifiers

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CPD-LRRK2R

Identifier Type: -

Identifier Source: org_study_id

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