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

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ClinicalTrials.gov Identifier: NCT02393027
Recruitment Status : Terminated (Enough inclusions for interpretation)
First Posted : March 19, 2015
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

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.


Condition or disease Intervention/treatment Phase
Idiopathic Parkinson Disease Drug: [18F] LBT-999 PET Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999
Study Start Date : March 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : May 2017


Arm Intervention/treatment
Experimental: patients
10 idopathic parkinson disease
Drug: [18F] LBT-999 PET
Active Comparator: controls subjects
10 healthy controls (no parkinson disease)
Drug: [18F] LBT-999 PET



Primary Outcome Measures :
  1. Binding potential of [18F] LBT-999 [ Time Frame: one year ]

Secondary Outcome Measures :
  1. DAT striatal density by estimating the LBT-999 distribution volume [ Time Frame: one year ]
  2. presence of lipophilic metabolites [ Time Frame: one year ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393027


Locations
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France
University Hospital
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Publications:

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02393027    
Other Study ID Numbers: PHAO14-MJR / LBT-999
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases