LRRK2 G2385R Leucocyte and Urine Biomarker Study

Parkinson Disease Clinical Trial

— LRRK2 G2385R  

Official title:

Identifying Leucocyte and Urine Biomarkers in Parkinson's Patients With LRRK2 G2385R Gene Variant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04436848
• Other study ID #: UMG2385R
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2020
• Source: University of Malaya
• Contact: Ai Huey Tan, MD, FRCP
• Phone: 60379492891
• Email: aihuey.tan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Given the emerging evidence on LRRK2-related biomarkers, this project will focus on identifying leucocyte and urine biomarkers that are altered by the LRRK2 G2385R variant, and investigating the effects of LRRK2 kinase inhibitor (MLi-2) on these biomarkers, using immunoblotting and mass spectrometry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Parkinson's disease assigned by a movement disorder specialist according to clinical diagnostic criteria

• Age above 18 year-old

• Provision of a written informed consent

Exclusion Criteria:

• Physical or mental incapacity to complete study protocol

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• This is a non-interventional study
This is a non-interventional study

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Centre	Kuala Lumpur

Sponsors (5)

Lead Sponsor	Collaborator
University of Malaya	Max Planck Institute of Biochemistry, Michael J. Fox Foundation for Parkinson's Research, Nextcea, Inc, University of Dundee

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of monocyte-based biomarkers for LRRK2 G2385R variant		Two years
Primary	Identification of urine-based biomarkers for LRRK2 G2385R variant		Two years