NCT01730599

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

Enrollment Period

2.6 years

First QC Date

October 22, 2012

Last Update Submit

November 15, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • change from baseline in updrs motor and total scores

    the participants will be followed for 5 years. the measurements will be taken evry 18 month.

Study Arms (1)

PD patients

PD patients carriers of the G2019S mutation in the LRRK2 gene

Other: neurological exam

Interventions

motor and cognitive functions

PD patients

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PD patients carriers of the G2019S mutation in the LRRK2 gene

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2012

First Posted

November 21, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Last Updated

November 21, 2012

Record last verified: 2012-11

Locations