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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01502384
Other study ID # TASMC-11-NG-0463
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 28, 2011
Last updated December 29, 2011
Start date January 2012

Study information

Verified date December 2011
Source Tel-Aviv Sourasky Medical Center
Contact Anat Mirelman, PhD
Phone 972-3-6974958
Email anatmi@tasmc.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 35 Years to 85 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- subjects with cognitive decline by the parameters defined in DSM- IV

- subjects with psychiatric disorder

- subjects unable to sign a consent form

Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


Intervention

Other:
neurological examination
motor and cognitive functions

Locations

Country Name City State
Israel Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (3)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center Beth Israel Medical Center, Columbia University

Country where clinical trial is conducted

Israel, 

References & Publications (12)

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. — View Citation

Di Monte DA, Lavasani M, Manning-Bog AB. Environmental factors in Parkinson's disease. Neurotoxicology. 2002 Oct;23(4-5):487-502. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Quik M. Smoking, nicotine and Parkinson's disease. Trends Neurosci. 2004 Sep;27(9):561-8. Review. — View Citation

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. Review. — View Citation

Vila M, Przedborski S. Genetic clues to the pathogenesis of Parkinson's disease. Nat Med. 2004 Jul;10 Suppl:S58-62. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

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