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

This study is not yet open for participant recruitment.
Verified November 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01730599
First received: October 22, 2012
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Parkinson's Disease
 Other: neurological exam

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PD patients
PD patients carriers of the G2019S mutation in the LRRK2 gene
 Other: neurological exam
motor and cognitive functions

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01730599     History of Changes
Other Study ID Numbers: TASMC-11-NG-0473
Study First Received: October 22, 2012
Last Updated: November 15, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013