NCT01502384

Brief Summary

This is a longitudinal study in healthy 1st degree relatives of patients with Parkinson's Disease (PD) carriers of a genetic mutation in genes that are known to increase the risk for PD. The purpose of this study is to explore the association between genetic mutations in the known genes and early preclinical symptoms such as motor, sensory, autonomic, behavioral and cognitive functions.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-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

December 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

December 30, 2011

Status Verified

December 1, 2011

Enrollment Period

3.4 years

First QC Date

December 28, 2011

Last Update Submit

December 29, 2011

Conditions

Parkinson's Disease

Keywords

healthy 1st degree relatives of pd patients

Study Arms (1)

healthy relatives

healthy 1st degree relatives of PD patients

Other: neurological examination

Interventions

neurological examinationOTHER

motor and cognitive functions

healthy relatives

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy 1ST degree realtives of PD patients

You may qualify if:

  • healthy 1ST degree relatives of PD patients with known genotype that participated in an earlier genetic study at the sourasky medical center.

You may not qualify if:

  • subjects with cognitive decline by the parameters defined in 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

Related Publications (12)

  • Di Monte DA. The environment and Parkinson's disease: is the nigrostriatal system preferentially targeted by neurotoxins? Lancet Neurol. 2003 Sep;2(9):531-8. doi: 10.1016/s1474-4422(03)00501-5.

    PMID: 12941575BACKGROUND

  • Di Monte DA, Lavasani M, Manning-Bog AB. Environmental factors in Parkinson's disease. Neurotoxicology. 2002 Oct;23(4-5):487-502. doi: 10.1016/s0161-813x(02)00099-2.

    PMID: 12428721BACKGROUND

  • Huang Y, Cheung L, Rowe D, Halliday G. Genetic contributions to Parkinson's disease. Brain Res Brain Res Rev. 2004 Aug;46(1):44-70. doi: 10.1016/j.brainresrev.2004.04.007.

    PMID: 15297154BACKGROUND

  • Quik M. Smoking, nicotine and Parkinson's disease. Trends Neurosci. 2004 Sep;27(9):561-8. doi: 10.1016/j.tins.2004.06.008.

    PMID: 15331239BACKGROUND

  • Vila M, Przedborski S. Genetic clues to the pathogenesis of Parkinson's disease. Nat Med. 2004 Jul;10 Suppl:S58-62. doi: 10.1038/nm1068.

    PMID: 15272270BACKGROUND

  • von Bohlen und Halbach O, Schober A, Krieglstein K. Genes, proteins, and neurotoxins involved in Parkinson's disease. Prog Neurobiol. 2004 Jun;73(3):151-77. doi: 10.1016/j.pneurobio.2004.05.002.

    PMID: 15236834BACKGROUND

  • Farrer M, Stone J, Mata IF, Lincoln S, Kachergus J, Hulihan M, Strain KJ, Maraganore DM. LRRK2 mutations in Parkinson disease. Neurology. 2005 Sep 13;65(5):738-40. doi: 10.1212/01.wnl.0000169023.51764.b0.

    PMID: 16157908BACKGROUND

  • Wilk JB, Lash TL. Risk factor studies of age-at-onset in a sample ascertained for Parkinson disease affected sibling pairs: a cautionary tale. Emerg Themes Epidemiol. 2007 Apr 4;4:1. doi: 10.1186/1742-7622-4-1.

    PMID: 17408493BACKGROUND

  • Orr-Urtreger A, Shifrin C, Rozovski U, Rosner S, Bercovich D, Gurevich T, Yagev-More H, Bar-Shira A, Giladi N. The LRRK2 G2019S mutation in Ashkenazi Jews with Parkinson disease: is there a gender effect? Neurology. 2007 Oct 16;69(16):1595-602. doi: 10.1212/01.wnl.0000277637.33328.d8.

    PMID: 17938369BACKGROUND

  • Clark LN, Nicolai A, Afridi S, Harris J, Mejia-Santana H, Strug L, Cote LJ, Louis ED, Andrews H, Waters C, Ford B, Frucht S, Fahn S, Mayeux R, Ottman R, Marder K. Pilot association study of the beta-glucocerebrosidase N370S allele and Parkinson's disease in subjects of Jewish ethnicity. Mov Disord. 2005 Jan;20(1):100-3. doi: 10.1002/mds.20320.

    PMID: 15517591BACKGROUND

  • Thaler A, Ash E, Gan-Or Z, Orr-Urtreger A, Giladi N. The LRRK2 G2019S mutation as the cause of Parkinson's disease in Ashkenazi Jews. J Neural Transm (Vienna). 2009 Nov;116(11):1473-82. doi: 10.1007/s00702-009-0303-0.

    PMID: 19756366BACKGROUND

  • Mirelman A, Gurevich T, Giladi N, Bar-Shira A, Orr-Urtreger A, Hausdorff JM. Gait alterations in healthy carriers of the LRRK2 G2019S mutation. Ann Neurol. 2011 Jan;69(1):193-7. doi: 10.1002/ana.22165.

    PMID: 21280089BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Anat Mirelman, PhD

CONTACT

972-3-6974958anatmi@tasmc.health.gov.il

Study Design

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

Study Record Dates

First Submitted

December 28, 2011

First Posted

December 30, 2011

Study Start

January 1, 2012

Primary Completion

June 1, 2015

Last Updated

December 30, 2011

Record last verified: 2011-12

Locations

IL(1)