Parkinson's DiseaseNCT01730599
A Longitudinal Study in Parkinson's Disease (PD) Patients
An observational study of Parkinson's Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This is a longitudinal study in patients with Parkinson's Disease (PD) carriers of a genetic mutation - substitution of gly with ser in position 2019 (G2019S) in the leucine-rich repeat kinase 2 (LRRK2) gene. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- neurological exam
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to Jun 2015
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PD patients carriers of the G2019S mutation in the LRRK2 gene
Who may be able to join
- parkinson'd disease patients that already participated in a pasr cross sectional study
Who cannot join
- subjects with cognitive decline by the parameters defined in Diagnostic and Statistical Manual of Mental Disorders (DSM)- IV
- subjects with psychiatric disorder
- subjects unable to sign a consent form
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Sourasky Medical Center
Tel Aviv
Anat Mirelman, PhD, 972-3-6973014, anatmi@tasmc.health.gov.il
About this study
Official title: A Longitudinal 5 Years Follow up Study in Parkinson's Disease (PD) Patients Carriers of the LRRK2 Gene G2019S Mutation
This is a longitudinal study in patients with Parkinson's Disease (PD) carriers of a genetic mutation - substitution of gly with ser in position 2019 (G2019S) in the leucine-rich repeat kinase 2 (LRRK2) gene. The purpose of this study is to explore the association between genetic mutations in the known genes and their influence on disease manifestation over few years of follow up
- Conditions
- Parkinson's Disease
- Being tested
- neurological exam
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurological examOther
motor and cognitive functions
| Study group | Role | What they receive |
|---|---|---|
| PD patients | PD patients carriers of the G2019S mutation in the LRRK2 gene Receives: Other: neurological exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in updrs motor and total scores
Measured: the participants will be followed for 5 years. the measurements will be taken evry 18 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Cohort
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730599
- Sponsor's protocol ID
- TASMC-11-NG-0473
- Status last verified
- Nov 2012
- First submitted
- 22 Oct 2012
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal 5 Years Follow up Study in Parkinson's Disease (PD) Patients Carriers of the LRRK2 Gene G2019S Mutation
- ClinicalTrials.gov ID
- NCT01730599
- Acronym / sponsor ID
- TASMC-11-NG-0473
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (estimated)
- First posted
- 21 Nov 2012 (estimated)
- 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.
This is a longitudinal study in patients with Parkinson's Disease (PD) carriers of a genetic mutation - substitution of gly with ser in position 2019 (G2019S) in the leucine-rich repeat kinase 2 (LRRK2) gene. The purpose of this study is to explore the association between genetic mutations in the known genes and their influence on disease manifestation over few years of follow up
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD patients | – | Other: neurological examPD patients carriers of the G2019S mutation in the LRRK2 gene |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PD patients carriers of the G2019S mutation in the LRRK2 gene
Key inclusion criteria (1 listed)
- parkinson'd disease patients that already participated in a pasr cross sectional study
Key exclusion criteria (3 listed)
- subjects with cognitive decline by the parameters defined in Diagnostic and Statistical Manual of Mental Disorders (DSM)- IV
- subjects with psychiatric disorder
- subjects unable to sign a consent form
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 |
|---|---|---|
| neurological exammotor and cognitive functions | Other | PD patients |
Primary outcome
change from baseline in updrs motor and total scores
Time frame: the participants will be followed for 5 years. the measurements will be taken evry 18 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
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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.
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's Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 inclusion and 3 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 21 Nov 2012. 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 Israel. 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 Anat Mirelman, PhD (972-3-6973014, anatmi@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in updrs motor and total scores (time frame: the participants will be followed for 5 years. the measurements will be taken evry 18 month.). 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 21 Nov 2012.