Parkinson DiseaseNCT01089283
Ioflupane I123 (DaTSCAN) and Positron Emission Tomography-computed Tomography Fludeoxyglucose (PET-CT FDG) to Assess Brain Function of Parkinson Patients With Different Genetic Characteristics
An observational study of Parkinson Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diagnosed parkinson patients ages: 40-80
Who may be able to join
- diagnosed Parkinson patients with known genetic characteristics
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
Tel Aviv
Einat Even-Sapir, MD, PhD, 972-3-6974444 ext. 3536, Evensap@tasmc.health.gov.il
Ayelet Kurzband, BA, 972-3-6974444 ext. 3536, ayeletk@tasmc.health.gov.il
About this study
Official title: 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.
Read more
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.
- Conditions
- Parkinson Disease
- Keywords
- parkinson, fdg pet-ct, i123 dat scan, LRRK2, GBA, parkinson patients with known genetic characteristic
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Einat Even-Sapir, MD, PhD, Principal investigator, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089283
- Sponsor's protocol ID
- TASMC-10-EES-087-CTIL
- Status last verified
- Mar 2010
- First submitted
- 17 Mar 2010
- Last updated
- 18 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 8691238Huang 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.
PubMed 15297154Vila M, Przedborski S. Genetic clues to the pathogenesis of Parkinson's disease. Nat Med. 2004 Jul;10 Suppl:S58-62. doi: 10.1038/nm1068.
PubMed 15272270von 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.
PubMed 15236834Farrer 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.
PubMed 16157908Orr-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.
PubMed 17938369Herholz 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.
PubMed 15262239Pavese 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.
PubMed 18992326Ozelius 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.
PubMed 16436782Thaler 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.
PubMed 19756366Hassin-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.
PubMed 19412725Gan-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.
PubMed 18434642Artzi 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.
PubMed 28406934
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I123 DAT-SCAN and PET-CT FDG to Assess Brain Function of Parkinson Patients With Different Genetic Characteristic
- ClinicalTrials.gov ID
- NCT01089283
- Acronym / sponsor ID
- TASMC-10-EES-087-CTIL
- Conditions
- Parkinson Disease
- Keywords
- parkinson, fdg pet-ct, i123 dat scan, LRRK2, GBA, parkinson patients with known genetic characteristic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (estimated)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed parkinson patients ages: 40-80
Key inclusion criteria (1 listed)
- diagnosed Parkinson patients with known genetic characteristics
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2010.
- Background: PubMed 8691238Volkow 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.
- Background: PubMed 15297154Huang 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.
- Background: PubMed 15272270Vila M, Przedborski S. Genetic clues to the pathogenesis of Parkinson's disease. Nat Med. 2004 Jul;10 Suppl:S58-62. doi: 10.1038/nm1068.
- Background: PubMed 15236834von 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.
- Background: PubMed 16157908Farrer 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.
- Background: PubMed 17938369Orr-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.
- Background: PubMed 15262239Herholz 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.
- Background: PubMed 18992326Pavese 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.
- Background: PubMed 16436782Ozelius 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.
- Background: PubMed 19756366Thaler 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.
- Background: PubMed 19412725Hassin-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.
- Background: PubMed 18434642Gan-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Einat Even-Sapir, MD, PhD principal investigator
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Einat Even-sapir, PhD, MD (972-3-6974444 ext. 3536, evensap@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01089283, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2010.