- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01089283
Ioflupane I123 (DaTSCAN) and Positron Emission Tomography-computed Tomography Fludeoxyglucose (PET-CT FDG) to Assess Brain Function of Parkinson Patients With Different Genetic Characteristics
I123 DAT-SCAN and PET-CT FDG to Assess Brain Function of Parkinson Patients With Different Genetic Characteristic
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Tel Aviv, Israel
- Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- diagnosed Parkinson patients with known genetic characteristics
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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LRRK2 mutation
Parkinson patients that carry mutation on LRRK2 gene
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GBA mutation
Parkinson patients that carry mutation on GBA gene
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no mutation
Parkinson patients that don't carry mutation on LRRK2 or GBA genes
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healthy
Healthy volunteers
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-10-EES-087-CTIL
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