LRRK2 G2385R Leucocyte and Urine Biomarker Study
LRRK2 G2385R
Identifying Leucocyte and Urine Biomarkers in Parkinson's Patients With LRRK2 G2385R Gene Variant
1 other identifier
observational
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
Typical duration for all trials
1 active site
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 Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 15, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJune 18, 2020
June 1, 2020
1.6 years
June 15, 2020
June 15, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Identification of monocyte-based biomarkers for LRRK2 G2385R variant
Two years
Identification of urine-based biomarkers for LRRK2 G2385R variant
Two years
Study Arms (3)
PD patients positive for LRRK2 G2385R
PD patients negative for LRRK2 G2385R
Non-PD controls negative for LRRK2 G2385R
Interventions
This is a non-interventional study
Eligibility Criteria
Patients with Parkinson's disease attending the Neurology outpatient clinic, at University of Malaya Medical Centre, Kuala Lumpur, Malaysia.
You may qualify if:
- 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
You may not qualify if:
- \- Physical or mental incapacity to complete study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Malayalead
- Michael J. Fox Foundation for Parkinson's Researchcollaborator
- University of Dundeecollaborator
- Nextcea, Inccollaborator
- Max Planck Institute of Biochemistrycollaborator
Study Sites (1)
University of Malaya Medical Centre
Kuala Lumpur, 50603, Malaysia
Biospecimen
Blood samples for extraction of DNA, monocytes and serum Urine samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ai Huey Tan, MD, FRCP
University of Malaya
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2020
First Posted
June 18, 2020
Study Start
June 1, 2020
Primary Completion
December 31, 2021
Study Completion
June 30, 2022
Last Updated
June 18, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
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.