NCT03523104

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Feb 2017Feb 2027

Study Start

First participant enrolled

February 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 29, 2018

Status Verified

April 1, 2018

Enrollment Period

10 years

First QC Date

May 1, 2018

Last Update Submit

May 24, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Database of Parkinson's disease with LRRK2 variants

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

    10 years

  • Clinical feature

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

    10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PD patients with LRRK2 variants

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

extraction of DNA from peripheral blood

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Jifeng Guo, Ph.D.

CONTACT

Beisha Tang, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2018

First Posted

May 14, 2018

Study Start

February 1, 2017

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

May 29, 2018

Record last verified: 2018-04

Locations