Ioflupane I123 (DaTSCAN) and Positron Emission Tomography-computed Tomography Fludeoxyglucose (PET-CT FDG) to Assess Brain Function of Parkinson Patients With Different Genetic Characteristics

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT01089283

First received: March 17, 2010

Last updated: NA

Last verified: March 2010

History: No changes posted

Purpose

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.

Condition
Parkinson Disease

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	I123 DAT-SCAN and PET-CT FDG to Assess Brain Function of Parkinson Patients With Different Genetic Characteristic

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: CT Scans Nuclear Scans Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment:	80
Study Start Date:	March 2010
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Diagnosed parkinson patients ages: 40-80

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089283

Contacts

Contact: Einat Even-sapir, PhD, MD	972-3-6974444 ext 3536	evensap@tasmc.health.gov.il
Contact: Ayelet Kurzband, BA	972-3-6974444 ext 3536	ayeletk@tasmc.health.gov.il

Locations

Israel
Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center	Not yet recruiting
Tel Aviv, Israel
Contact: Einat Even-Sapir, MD, PhD 972-3-6974444 ext 3536 Evensap@tasmc.health.gov.il
Contact: Ayelet Kurzband, BA 972-3-6974444 ext 3536 ayeletk@tasmc.health.gov.il
Sub-Investigator: Hedva Lerman, MD
Sub-Investigator: Nir Giladi, PhD, MD
Sub-Investigator: Anat Milerman

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator:

Einat Even-Sapir, MD, PhD

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

More Information

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.

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.

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

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.

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.

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.

Herholz K, Heiss WD. Positron emission tomography in clinical neurology. Mol Imaging Biol. 2004 Jul-Aug;6(4):239-69. Review.

Pavese N, Brooks DJ. Imaging neurodegeneration in Parkinson's disease. Biochim Biophys Acta. 2009 Jul;1792(7):722-9. Epub 2008 Oct 17. Review.

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. No abstract available.

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. 2009 Nov;116(11):1473-82. Review.

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. Epub 2009 Mar 24.

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. Epub 2008 Apr 23.

Responsible Party:	Einat Even-Sapir MD, PhD. Head, Dept of Nuclear Medicine, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT01089283 History of Changes
Other Study ID Numbers:	TASMC-10-EES-087-CTIL
Study First Received:	March 17, 2010
Last Updated:	March 17, 2010
Health Authority:	Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:

parkinson
fdg pet-ct
i123 dat scan

LRRK2
GBA
parkinson patients with known genetic characteristic

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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