LRRK2 G2385R Leucocyte and Urine Biomarker Study (LRRK2 G2385R)

June 15, 2020 updated by: University of Malaya

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 50603
        • Recruiting
        • University of Malaya Medical Centre
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Lei Cheng Lit, PhD
        • Sub-Investigator:
          • Azlina Ahmad Annuar, PhD
        • Sub-Investigator:
          • Yet Hoi Hong, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's disease attending the Neurology outpatient clinic, at University of Malaya Medical Centre, Kuala Lumpur, Malaysia.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PD patients positive for LRRK2 G2385R
Other: This is a non-interventional study
This is a non-interventional study
PD patients negative for LRRK2 G2385R
Other: This is a non-interventional study
This is a non-interventional study
Non-PD controls negative for LRRK2 G2385R
Other: This is a non-interventional study
This is a non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of monocyte-based biomarkers for LRRK2 G2385R variant
Time Frame: Two years
Two years
Identification of urine-based biomarkers for LRRK2 G2385R variant
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Collaborators

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

Investigators

  • Principal Investigator: Ai Huey Tan, MD, FRCP, University of Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMG2385R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified clinical data will be kept for storage at a central repository either hosted by the funder (Michael J. Fox Foundation), its collaborators, or consultants and will be made publicly available (with no personal identifying information) for the intended use of research in Parkinson's disease as well as other biomedical research studies that may not be related to Parkinson's disease.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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