Parkinson DiseaseLRRK2 G2385RNCT04436848
LRRK2 G2385R Leucocyte and Urine Biomarker Study
An observational study of Parkinson Disease, run by University of Malaya at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- This is a non-interventional study
- How many people
- 150 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's disease attending the Neurology outpatient clinic, at University of Malaya Medical Centre, Kuala Lumpur, Malaysia.
Who may be able to join
- 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
Who cannot join
- Physical or mental incapacity to complete study protocol
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University of Malaya Medical Centre
Kuala Lumpur, 50603
Ai Huey Tan, 60379492891, aihuey.tan@gmail.com
Shen Yang Lim, 60379492891, limshenyang@gmail.com
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- This is a non-interventional study
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a non-interventional studyOther
This is a non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| PD patients positive for LRRK2 G2385R | Not described Receives: Other: This is a non-interventional study | |
| PD patients negative for LRRK2 G2385R | Not described Receives: Other: This is a non-interventional study | |
| Non-PD controls negative for LRRK2 G2385R | Not described Receives: Other: This is a non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of monocyte-based biomarkers for LRRK2 G2385R variant
Measured: Two years
Identification of urine-based biomarkers for LRRK2 G2385R variant
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, University of Dundee, Nextcea, Inc, Max Planck Institute of Biochemistry
- Responsible party
- Sponsor
- Investigators
- Ai Huey Tan, MD, FRCP, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436848
- Sponsor's protocol ID
- UMG2385R
- Acronym
- LRRK2 G2385R
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Leucocyte and Urine Biomarkers in Parkinson's Patients With LRRK2 G2385R Gene Variant
- ClinicalTrials.gov ID
- NCT04436848
- Acronym / sponsor ID
- LRRK2 G2385R / UMG2385R
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, University of Dundee, Nextcea, Inc, Max Planck Institute of Biochemistry
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease attending the Neurology outpatient clinic, at University of Malaya Medical Centre, Kuala Lumpur, Malaysia.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Physical or mental incapacity to complete study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a non-interventional studyThis is a non-interventional study | Other | Non-PD controls negative for LRRK2 G2385R, PD patients negative for LRRK2 G2385R, PD patients positive for LRRK2 G2385R |
Primary outcome
Identification of monocyte-based biomarkers for LRRK2 G2385R variant
Time frame: Two years
Identification of urine-based biomarkers for LRRK2 G2385R variant
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ai Huey Tan, MD, FRCP principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ai Huey Tan, MD, FRCP (60379492891, aihuey.tan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of monocyte-based biomarkers for LRRK2 G2385R variant (time frame: Two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020; AzTrials last refreshed its copy on 6 Nov 2026.