MedTrace Logo

Microglial Activation in Narcolepsy Type 1 and Kleine-Levin Syndrome: Positron Emission Tomography (PET) Study in [18F] DPA-714

NCT03754348 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-05-29

No results posted yet for this study

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.

Conditions

  • Narcolepsy 1
  • Kleine-Levin Syndrome

Interventions

RADIATION

PET scan with tracer injection [18F] DPA-714

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2021-11-18
Completion
2021-11-18

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03754348 on ClinicalTrials.gov