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A Longitudinal Study in Parkinson's Disease (PD) Patients

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ClinicalTrials.gov Identifier: NCT01730599
Recruitment Status : Unknown
Verified November 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 21, 2012
Last Update Posted : November 21, 2012
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief 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. 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

Condition or disease Intervention/treatment
Parkinson's Disease Other: neurological exam

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Official Title: A Longitudinal 5 Years Follow up Study in Parkinson's Disease (PD) Patients Carriers of the LRRK2 Gene G2019S Mutation
Study Start Date : November 2012
Estimated Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
PD patients
PD patients carriers of the G2019S mutation in the LRRK2 gene
Other: neurological exam
motor and cognitive functions



Primary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PD patients carriers of the G2019S mutation in the LRRK2 gene
Criteria

Inclusion Criteria:

  • parkinson'd disease patients that already participated in a pasr cross sectional study

Exclusion Criteria:

  • 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

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): NCT01730599


Contacts
Contact: Anat Mirelman, PhD 972-3-6973014 anatmi@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Anat Mirelman, PhD    972-3-6973014    anatmi@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01730599     History of Changes
Other Study ID Numbers: TASMC-11-NG-0473
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: November 21, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases