NCT01089283

Brief Summary

Parkinson disease is one of the most common neurodegenerative illnesses. The disease is characterized by decrease in dopamine levels and decrease in the number of dopaminergic neurons and dopamine receptors. There are gene mutations that increase the risk for the disease. Two of those mutations are on the LRRK2 gene and on GBA gene. It is yet unknown if there is a difference between the metabolic brain function of Parkinson patients that carry one of the two mutations to Parkinson patients with no known mutation. Participants: diagnosed Parkinson patients that carry a gene mutation in either LRRK2 or GBA genes, Parkinson patients with no known mutation and healthy volunteers as a control group. The participants will go through both examinations DAT SCAN and PET CT SCAN at the Tel Aviv Sourasky Medical Center Nuclear Medicine Institute. The examination results will be given to the participants by a doctor from the neurology department.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
80

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

Study Start

First participant enrolled

March 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Last Updated

March 18, 2010

Status Verified

March 1, 2010

Enrollment Period

1 year

First QC Date

March 17, 2010

Last Update Submit

March 17, 2010

Conditions

Parkinson Disease

Keywords

parkinsonfdg pet-cti123 dat scanLRRK2GBAparkinson patients with known genetic characteristic

Study Arms (4)

LRRK2 mutation

Parkinson patients that carry mutation on LRRK2 gene

GBA mutation

Parkinson patients that carry mutation on GBA gene

no mutation

Parkinson patients that don't carry mutation on LRRK2 or GBA genes

healthy

Healthy volunteers

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diagnosed parkinson patients ages: 40-80

You may qualify if:

  • diagnosed Parkinson patients with known genetic characteristics

You may not qualify if:

  • patients unable to understand and sign an informed consent
  • minors
  • patients in medical condition that does not allow them to stay still during the examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Related Publications (13)

  • Volkow ND, Ding YS, Fowler JS, Wang GJ, Logan J, Gatley SJ, Hitzemann R, Smith G, Fields SD, Gur R. Dopamine transporters decrease with age. J Nucl Med. 1996 Apr;37(4):554-9.

    PMID: 8691238BACKGROUND

  • 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

  • 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

  • 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

  • Herholz K, Heiss WD. Positron emission tomography in clinical neurology. Mol Imaging Biol. 2004 Jul-Aug;6(4):239-69. doi: 10.1016/j.mibio.2004.05.002.

    PMID: 15262239BACKGROUND

  • Pavese N, Brooks DJ. Imaging neurodegeneration in Parkinson's disease. Biochim Biophys Acta. 2009 Jul;1792(7):722-9. doi: 10.1016/j.bbadis.2008.10.003. Epub 2008 Oct 17.

    PMID: 18992326BACKGROUND

  • Ozelius LJ, Senthil G, Saunders-Pullman R, Ohmann E, Deligtisch A, Tagliati M, Hunt AL, Klein C, Henick B, Hailpern SM, Lipton RB, Soto-Valencia J, Risch N, Bressman SB. LRRK2 G2019S as a cause of Parkinson's disease in Ashkenazi Jews. N Engl J Med. 2006 Jan 26;354(4):424-5. doi: 10.1056/NEJMc055509. No abstract available.

    PMID: 16436782BACKGROUND

  • 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

  • Hassin-Baer S, Laitman Y, Azizi E, Molchadski I, Galore-Haskel G, Barak F, Cohen OS, Friedman E. The leucine rich repeat kinase 2 (LRRK2) G2019S substitution mutation. Association with Parkinson disease, malignant melanoma and prevalence in ethnic groups in Israel. J Neurol. 2009 Mar;256(3):483-7. doi: 10.1007/s00415-009-0117-x. Epub 2009 Mar 24.

    PMID: 19412725BACKGROUND

  • Gan-Or Z, Giladi N, Rozovski U, Shifrin C, Rosner S, Gurevich T, Bar-Shira A, Orr-Urtreger A. Genotype-phenotype correlations between GBA mutations and Parkinson disease risk and onset. Neurology. 2008 Jun 10;70(24):2277-83. doi: 10.1212/01.wnl.0000304039.11891.29. Epub 2008 Apr 23.

    PMID: 18434642BACKGROUND

  • Artzi M, Even-Sapir E, Lerman Shacham H, Thaler A, Urterger AO, Bressman S, Marder K, Hendler T, Giladi N, Ben Bashat D, Mirelman A. DaT-SPECT assessment depicts dopamine depletion among asymptomatic G2019S LRRK2 mutation carriers. PLoS One. 2017 Apr 13;12(4):e0175424. doi: 10.1371/journal.pone.0175424. eCollection 2017.

    PMID: 28406934DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Einat Even-Sapir, MD, PhD

    Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Einat Even-sapir, PhD, MD

CONTACT

972-3-6974444evensap@tasmc.health.gov.il

Ayelet Kurzband, BA

CONTACT

972-3-6974444ayeletk@tasmc.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 17, 2010

First Posted

March 18, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2011

Last Updated

March 18, 2010

Record last verified: 2010-03

Locations

IL(1)