To study in vivo microglial activation by PET [18F] DPA-714 in NT1 patients with recent evolution (appearance of the first symptoms - somnolence and cataplexy-less than 2 years ago) compared with controlled subjects (followed for another pathology of sleep without narcolepsy or hypersomnia) matched in age and sex.
Conditions
Interventions
Product Name: N,N-diethyl-2-[4-(2-fluoroethoxy)phenyl]-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide
Pharmaceutical Form: Solution for solution for injection
Sponsors
University Hospital of Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Narcoleptic patients Inclusion Criteria : - Clinical diagnosis of NT1 according to International Classification of Sleep Disorders, 3rd Edition (AASM: American Academy of Sleep Medicine, 2014), with beginning of symptoma since 2 years top (somnolence and/or cataplexy) - With or without psychostimulant treatment for the pathology Control patients Inclusion Criteria : - Sleep disorder without objectification of narcolepsy or hypersomnia and without any inflammatory pathology. Non-specific Inclusion Criteria : - Age over 18 - Absence of contraindication to the performance of PET [18F] DPA-714 - Absence of immunomodulatory or anti-inflammatory treatment - Subjects having given their written and informed consent for this study - Subjects speaking and including French - Affiliated to social security Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Exclusion Criteria (non-specific patients/control) : - Refusal to perform PET Imaging in [18F] DPA-714 - Pregnant or lactating women - Subject deprived of liberty, by judicial or administrative decision - Major protected by law - Subject without social security - Subject in exclusion period after another protocol - Refusal to participate in the protocol - Contraindications to MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study hypothalamic cerebral microglial activation in NT1 patients compared to matched controls in age and sex. The PET [18F] DPA-714 data will be recalibrated on a cerebral MRI for the SPM standardization step, then hypothalamic interest volumes (VOI) will be isolated and a semi-quantitative evaluation will be performed at various instants of time. dynamic acquisition.;Secondary Objective: To study the relationship between (1) microglial activation in the whole brain, at the level of the hypothalamus and neighboring regions (thalamus), and (2) clinical characteristics (age of onset of symptoms, duration of evolution , severity of symptoms) and polysomnographic, and (3) Hcrt levels in the CSF, and proinflammatory cytokines in the CSF and serum in the NT1 patient population.;Primary end point(s): Hypothalamic microglial activation level, using [18F] DPA-714 dynamic PET data (in 40 minute LIST mode).;Timepoint(s) of evaluation of this end point: 1 month after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Search of the links between: (1) The mean [18F] DPA-714 SUV measurement at the different regions of interest (including the hypothalamus and thalamus) defined in brain CT after MRI referral and anatomical standardization in the MNI space, and (2) The clinical data of the disease (age of onset of symptoms, severity of symptoms), and electrophysiology (sleep latency and number of sleep in paradoxical sleep), (3) Hcrt levels in CSF and pro-inflammatory cytokines measured in serum and CSF of narcoleptic patients.;Timepoint(s) of evaluation of this end point: 1 month after inclusion | — |
Countries
France
Contacts
Public ContactResearch Departmen _ sponsor Unit
Research Department of Montpellier Hospital
Outcome results
None listed