LRRK2 G2385R Leucocyte and Urine Biomarker Study | NCT04436848

Studies
LRRK2 G2385R Leucocyte and Urine Biomarker Study

NCT04436848

Sponsor

University of Malaya

Status

Unknown status

Last Update Posted

Jun 18, 2020Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Parkinson Disease

Interventions

This is a non-interventional study

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Jun 30, 2022Estimated

First Submitted Date

Jun 15, 2020

First Submission Date that Met QC Criteria

Jun 15, 2020

First Posted Date

Jun 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2020

Last Update Posted Date

Jun 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University of MalayaOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PD patients positive for LRRK2 G2385R			Other: This is a non-interventional study
PD patients negative for LRRK2 G2385R			Other: This is a non-interventional study
Non-PD controls negative for LRRK2 G2385R			Other: This is a non-interventional study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
This is a non-interventional study	Other	This is a non-interventional study	Non-PD controls negative for LRRK2 G2385R PD patients negative for LRRK2 G2385R

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ai Huey Tan, MD, FRCP	Contact	60379492891		aihuey.tan@gmail.com
Shen Yang Lim, MD, FRACP	Contact	60379492891		limshenyang@gmail.com

Overall Officials

Name	Affiliation	Role
Ai Huey Tan, MD, FRCP	University of Malaya	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Malaya Medical Centre	Recruiting	Kuala Lumpur		50603	Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided