NCT02393027

Brief Summary

Idiopathic Parkinson's disease (IPD) is a degenerative disease affecting the dopaminergic system. Clinical symptoms of IPD commonly begin after the loss of at least 40 to 50% of striatal dopaminergic terminals (specially putaminal terminals). The Dopamine neuronal transporter (DAT) is a highly expressed protein in the membrane of presynaptic nigrostriatal dopaminergic terminals. The use of a DAT's radioligand in the initial stages of the disease would lead to an early detection of nigral cell loss. Currently, only one DAT's radioligand has obtained marketing authorization in France, the 123I-FPCIT, for use in Single Photon Emission Computed Tomography (SPECT). Otherwise, the Positron Emission Tomography (PET), a more sensitive technology than SPECT with higher resolution has become for a few years the new gold standard for visual analysis and quantification of neurotransmission systems (including the dopaminergic system). A DAT tracer labelled with Carbon 11 (\[11C\] PE2l) have been developed and is currently used as a reference in various research centers. However, in order to enable a clinical use of this tracer (which currently can't be because of the too short period of Carbon 11), the unit INSERM U930 "Imaging and Brain" in collaboration with the CERRP (Center for Studies and Research on Radiopharmaceuticals) developed a new version of this tracer, labelled with 18-fluor: the \[18F\] LBT-999. The main goal of this study is to compare the \[18F\] LBT-999 uptake between a group of patients suffering from a Parkinsonien syndrome to a group healthy volunteers.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2015

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.7 years

First QC Date

March 6, 2015

Last Update Submit

May 24, 2017

Conditions

Idiopathic Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Binding potential of [18F] LBT-999

    one year

Secondary Outcomes (2)

  • DAT striatal density by estimating the LBT-999 distribution volume

    one year

  • presence of lipophilic metabolites

    one year

Study Arms (2)

patients

EXPERIMENTAL

10 idopathic parkinson disease

Drug: [18F] LBT-999 PET

controls subjects

ACTIVE COMPARATOR

10 healthy controls (no parkinson disease)

Drug: [18F] LBT-999 PET

Interventions

[18F] LBT-999 PETDRUG
controls subjectspatients

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Criteria common to all participants:
  • Age between 45 and 75 years old
  • Signed informed consent
  • Affiliated to a social security system
  • Criteria for patients:
  • idiopathic Parkinson's disease according to the UKPDSBB criteria
  • stage 1-3 Hoen and Yahr (unilateral disease to moderate or mild bilateral disease in a self patient )
  • Criteria for healthy volunteers:
  • matching according to age (± 5 years)

You may not qualify if:

  • Criteria common to all participants:
  • history of taking an antipsychotic or any other drug with a dopaminergic effect in the previous 6 months
  • contraindications to MRI
  • person with severe claustrophobia
  • patient with a legal protection measure
  • alcohol or drug abuse history (in the past 10 years)
  • history of progressive disease that can affect the central nervous system (blood pressure greater than or equal to 180/100 mmHg, chronic lung disease with hypoxia, heart failure stage 4)
  • all medical and surgical affection older than 3 months
  • history of stroke
  • history of head trauma (coma\> 24h)
  • MMS\<24
  • pregnancy or lactating woman without reliable contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Tours, 37044, France

Location

Related Publications (12)

  • Agid Y. Parkinson's disease: pathophysiology. Lancet. 1991 Jun 1;337(8753):1321-4. doi: 10.1016/0140-6736(91)92989-f. No abstract available.

    PMID: 1674304BACKGROUND

  • Brooks DJ, Pavese N. Imaging biomarkers in Parkinson's disease. Prog Neurobiol. 2011 Dec;95(4):614-28. doi: 10.1016/j.pneurobio.2011.08.009. Epub 2011 Aug 30.

    PMID: 21896306BACKGROUND

  • Brooks DJ. Imaging dopamine transporters in Parkinson's disease. Biomark Med. 2010 Oct;4(5):651-60. doi: 10.2217/bmm.10.86.

    PMID: 20945978BACKGROUND

  • Chalon S, Hall H, Saba W, Garreau L, Dolle F, Halldin C, Emond P, Bottlaender M, Deloye JB, Helfenbein J, Madelmont JC, Bodard S, Mincheva Z, Besnard JC, Guilloteau D. Pharmacological characterization of (E)-N-(4-fluorobut-2-enyl)-2beta-carbomethoxy-3beta-(4'-tolyl)nortropane (LBT-999) as a highly promising fluorinated ligand for the dopamine transporter. J Pharmacol Exp Ther. 2006 Apr;317(1):147-52. doi: 10.1124/jpet.105.096792. Epub 2005 Dec 9.

    PMID: 16339913BACKGROUND

  • de Rijk MC, Tzourio C, Breteler MM, Dartigues JF, Amaducci L, Lopez-Pousa S, Manubens-Bertran JM, Alperovitch A, Rocca WA. Prevalence of parkinsonism and Parkinson's disease in Europe: the EUROPARKINSON Collaborative Study. European Community Concerted Action on the Epidemiology of Parkinson's disease. J Neurol Neurosurg Psychiatry. 1997 Jan;62(1):10-5. doi: 10.1136/jnnp.62.1.10.

    PMID: 9010393BACKGROUND

  • Fernagut PO, Li Q, Dovero S, Chan P, Wu T, Ravenscroft P, Hill M, Chen Z, Bezard E. Dopamine transporter binding is unaffected by L-DOPA administration in normal and MPTP-treated monkeys. PLoS One. 2010 Nov 22;5(11):e14053. doi: 10.1371/journal.pone.0014053.

    PMID: 21124922BACKGROUND

  • Hsiao IT, Weng YH, Lin WY, Hsieh CJ, Wey SP, Yen TC, Kung MP, Lu CS, Lin KJ. Comparison of 99mTc-TRODAT-1 SPECT and 18 F-AV-133 PET imaging in healthy controls and Parkinson's disease patients. Nucl Med Biol. 2014 Apr;41(4):322-9. doi: 10.1016/j.nucmedbio.2013.12.017. Epub 2014 Jan 10.

    PMID: 24503330BACKGROUND

  • Serriere S, Tauber C, Vercouillie J, Guilloteau D, Deloye JB, Garreau L, Galineau L, Chalon S. In vivo PET quantification of the dopamine transporter in rat brain with [(1)(8)F]LBT-999. Nucl Med Biol. 2014 Jan;41(1):106-13. doi: 10.1016/j.nucmedbio.2013.09.007. Epub 2013 Oct 8.

    PMID: 24210285BACKGROUND

  • Schillaci O, Pierantozzi M, Filippi L, Manni C, Brusa L, Danieli R, Bernardi G, Simonetti G, Stanzione P. The effect of levodopa therapy on dopamine transporter SPECT imaging with( 123)I-FP-CIT in patients with Parkinson's disease. Eur J Nucl Med Mol Imaging. 2005 Dec;32(12):1452-6. doi: 10.1007/s00259-005-1922-9. Epub 2005 Sep 8.

    PMID: 16151764BACKGROUND

  • Sharma S, Moon CS, Khogali A, Haidous A, Chabenne A, Ojo C, Jelebinkov M, Kurdi Y, Ebadi M. Biomarkers in Parkinson's disease (recent update). Neurochem Int. 2013 Sep;63(3):201-29. doi: 10.1016/j.neuint.2013.06.005. Epub 2013 Jun 19.

    PMID: 23791710BACKGROUND

  • Snow BJ, Tooyama I, McGeer EG, Yamada T, Calne DB, Takahashi H, Kimura H. Human positron emission tomographic [18F]fluorodopa studies correlate with dopamine cell counts and levels. Ann Neurol. 1993 Sep;34(3):324-30. doi: 10.1002/ana.410340304.

    PMID: 8363349BACKGROUND

  • Varrone A, Stepanov V, Nakao R, Toth M, Gulyas B, Emond P, Deloye JB, Vercouillie J, Stabin MG, Jonsson C, Guilloteau D, Halldin C. Imaging of the striatal and extrastriatal dopamine transporter with (18)F-LBT-999: quantification, biodistribution, and radiation dosimetry in nonhuman primates. J Nucl Med. 2011 Aug;52(8):1313-21. doi: 10.2967/jnumed.111.089953. Epub 2011 Jul 15.

    PMID: 21764797BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 19, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2016

Study Completion

May 1, 2017

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

FR(1)