Microglial Activation in Narcolepsy Type 1 and Kleine-Levin Syndrome: Positron Emission Tomography (PET) Study in [18F] DPA-714
NARCOGLIE
1 other identifier
interventional
78
1 country
1
Brief Summary
Type 1 narcolepsy (NT1) is a chronic sleep disorder caused by the selective and irreversible loss of neurons from the hypothalamus, which synthesizes a neurotransmitter: hypocretin (Hcrt) / orexin. The exact cause of this destruction is still unknown, but the autoimmune hypothesis is strongly favored, involving the interaction of genetic and environmental factors. The treatment of NT1 is currently only symptomatic, targeting hypersomnolence and cataplexy. To prevent the destruction of Hcrt neurons, immunomodulatory agents have been tested, with varying efficacy, probably due to varying degrees of hypothalamic impairment and stages of disease progression. During microglial activation, a condition associated with neuroinflammation in the brain, there is an increase in the mitochondrial translocation protein (TSPO), which can be quantified in vivo by specific tracers, such as the \[18F\] DPA- 714, in positron emission tomography (PET), a very sensitive nuclear imaging technique. The aim here is to study microglial activation in PET \[18F\] DPA-714 in NT1 patients with recent evolution in comparison with controls; then analyze the effect of age, and the severity of symptoms on this PET imaging biomarker. The hypothesis is that microglial activation, especially of the hypothalamic region, is greater in NT1 than controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
November 5, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedStudy Start
First participant enrolled
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2021
CompletedMay 29, 2024
March 1, 2022
2.8 years
November 5, 2018
May 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantification of microglial activation in the hypothalamus (SuVr) of adult NT1 patients compared to controls
1 day
Secondary Outcomes (5)
Correlation between microglial activation in the hypothalamus, thalamus, and other regions of interest in adult and child patients and severity of the disease
1 day
Correlation between microglial activation in the hypothalamus, thalamus, and other regions of interest in adult and child patients and electrophysiological biomarkers
1 day
Correlation between microglial activation in the hypothalamus, thalamus, and other regions of interest in adult and child patients and inflammatory biomarkers
1 day
Microglial activation in the hypothalamus, thalamus, and other regions of interest in KLS patients vs NT1 patients
1 day
Correlation between microglial activation in the hypothalamus, thalamus, and other regions of interest in KLS patients and time and severity of the disease (clinical, polysomnographic and biologic parameters)
1 day
Study Arms (3)
NT1 group
EXPERIMENTALhypothalamus neuroinflammation evaluation in Narcoleptic patients
Control group
OTHERhypothalamus neuroinflammation evaluation in control patients (patients without hypersomnia or inflammatory pathology)
KLS group
EXPERIMENTALhypothalamus neuroinflammation evaluation in Kleine-Levin syndrome patients
Interventions
the subject will receive a dose of 3.5MBq / kg intravenous (in bolus) more or less 20%, knowing that the minimum dose injected is unchanged at 150MBq and the maximum dose at 370 MBq. Irradiation will remain below 10 mSv
Eligibility Criteria
You may qualify if:
- For all groups :
- Written agreement for participation
- Able to understand instructions and information data
- Without any immunomodulatory, immunosuppressant, or anti-inflamatory medication
- For NT1 patients:
- years-old or more
- Responding to NT1 criteria (ICSD-3)
- Under psychostimulant or not for narcolepsy
- For KLS patients:
- years-old or more
- KLS diagnosis
- For controls
- years-old or more
- Absence of narcolepsy
- Absence of acute or chronic inflammatory disease
You may not qualify if:
- People without public insurance regime
- Specific contraindication to the use of PET (specific allergy related to the ligand).
- Pregnant and breastfeeding women
- Persons deprived of liberty by judicial or administrative decision
- People hospitalized without consent, or subject to legal protection
- Persons unable to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Montpellier
Montpellier, France
Related Publications (1)
Barateau L, Krache A, Da Costa A, Lecendreux M, Debs R, Chenini S, Arlicot N, Vourc'h P, Evangelista E, Alonso M, Salabert AS, Silva S, Beziat S, Jaussent I, Mariano-Goulart D, Payoux P, Dauvilliers Y. Microglia Density and Its Association With Disease Duration, Severity, and Orexin Levels in Patients With Narcolepsy Type 1. Neurology. 2024 May;102(10):e209326. doi: 10.1212/WNL.0000000000209326. Epub 2024 Apr 26.
PMID: 38669634DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2018
First Posted
November 27, 2018
Study Start
January 15, 2019
Primary Completion
November 18, 2021
Study Completion
November 18, 2021
Last Updated
May 29, 2024
Record last verified: 2022-03