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Idiopathic Parkinson DiseaseEarly Phase 1LBT 999NCT02393027

Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999

A Early Phase 1 study testing [18F] LBT-999 PET in people with Idiopathic Parkinson Disease, run by University Hospital, Tours at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 45 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Idiopathic Parkinson Disease
What is being tested?
[18F] LBT-999 PET
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteFrance
Study dates
Mar 2015to May 2017
Phase
Early Phase 1
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 45 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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)

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Hospital

    Tours, 37044

Other trials in France

About this study

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.

Read more

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.

Being tested
[18F] LBT-999 PET
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F] LBT-999 PETDrug

Study groups in NCT02393027
Study groupRoleWhat they receive
patientsExperimental10 idopathic parkinson disease
Receives: Drug: [18F] LBT-999 PET
controls subjectsActive comparator10 healthy controls (no parkinson disease)
Receives: Drug: [18F] LBT-999 PET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Binding potential of [18F] LBT-999

    Measured: one year

Secondary outcomes (2)

  1. DAT striatal density by estimating the LBT-999 distribution volume

    Measured: one year

  2. presence of lipophilic metabolites

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionNov 2016
  4. Study completionMay 2017

Why it stopped: Enough inclusions for interpretation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02393027
Sponsor's protocol ID
PHAO14-MJR / LBT-999
Acronym
LBT 999
Status last verified
May 2017
First submitted
6 Mar 2015
Last updated
30 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 1674304

  • 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.

    PubMed 21896306

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

    PubMed 20945978

  • 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.

    PubMed 16339913

  • 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.

    PubMed 9010393

  • 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.

    PubMed 21124922

  • 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.

    PubMed 24503330

  • 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.

    PubMed 24210285

  • 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.

    PubMed 16151764

  • 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.

    PubMed 23791710

  • 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.

    PubMed 8363349

  • 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.

    PubMed 21764797

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [18F] LBT-999 PET in people with Idiopathic Parkinson Disease, run by University Hospital, Tours at 1 site in France.

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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 30 May 2017. 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 France. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Enough inclusions for interpretation). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Binding potential of [18F] LBT-999 (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02393027, which also lists 12 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 30 May 2017.

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