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LRRK2 G2385R Leucocyte and Urine Biomarker Study (LRRK2 G2385R)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436848
Recruitment Status : Unknown
Verified June 2020 by University of Malaya.
Recruitment status was:  Recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
University of Dundee
Nextcea, Inc
Max Planck Institute of Biochemistry
Information provided by (Responsible Party):
University of Malaya

Study Description
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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.

Condition or disease Intervention/treatment
Parkinson Disease Other: This is a non-interventional study

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Identifying Leucocyte and Urine Biomarkers in Parkinson's Patients With LRRK2 G2385R Gene Variant
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Identification of monocyte-based biomarkers for LRRK2 G2385R variant [ Time Frame: Two years ]
  2. Identification of urine-based biomarkers for LRRK2 G2385R variant [ Time Frame: Two years ]

Biospecimen Retention:   Samples With DNA
Blood samples for extraction of DNA, monocytes and serum Urine samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436848


Contacts
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Contact: Ai Huey Tan, MD, FRCP 60379492891 aihuey.tan@gmail.com
Contact: Shen Yang Lim, MD, FRACP 60379492891 limshenyang@gmail.com

Locations
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Malaysia
University of Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 50603
Contact: Ai Huey Tan    60379492891    aihuey.tan@gmail.com   
Contact: Shen Yang Lim    60379492891    limshenyang@gmail.com   
Sub-Investigator: Lei Cheng Lit, PhD         
Sub-Investigator: Azlina Ahmad Annuar, PhD         
Sub-Investigator: Yet Hoi Hong, PhD         
Sponsors and Collaborators
University of Malaya
Michael J. Fox Foundation for Parkinson's Research
University of Dundee
Nextcea, Inc
Max Planck Institute of Biochemistry
Investigators
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Principal Investigator: Ai Huey Tan, MD, FRCP University of Malaya
More Information
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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT04436848    
Other Study ID Numbers: UMG2385R
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases