delirium
Conditions
Interventions
Product Name: [18F]N,N-diethyl-2-[2-(4-(2fluoroethoxy)phenyl)-5,7dimethylpyrazolo[1,5-a]pyrimidin-3yl]acetamide
Product Code: [18F]DPA-71
Pharmaceutical Form: Solution for injection
Sponsors
University Hospital of Toulouse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients (male or female > or = 18 years) - COVID-19 (positive respiratory track PCR test =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - medical decision of withdrawal of life sustaining treatments previous to patients recruitment - former neurological or psychiatric disability - MRI or PET scan contraindication - pregnancy or breastfeeding - hemodynamic or respiratory failure precluding patient’s transport / MRI or PET scanning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: o describe whole-brain changes in microglial activity in patients with Covid-19 and delirium during the acute phase of delirium.;Secondary Objective: - Identification of structural and functional abnormalities of the whole brain in magnetic resonance imaging (MRI) in patients at V1 and 3 months after (V2). - Study of the cerebral neurotropism of CoV-2-CoV-SARS quasispecies at V1 and V2 - Description of the central and peripheral immune response to V1 and V2 - Simple (V1) and multidimensional (V2) neurocognitive assessment to explore patient outcomes and cognitive impact of delirium - Comparison between the parameters evaluated at V1 and V2 (microglial activation, structural and functional cerebral modifications, neurotropism, central and peripheral immune response, neuropsychological evaluation) to characterize the impact of delirium on the evolution and fate of patients;Primary end point(s): Intensity and topography of microglial activation, marked in vivo by [18F]DPA-714 during PET imaging examination during the acute phase of delirium (V1). The phenotype of TSPO will be taken into account in the analyses of the PET scan results.;Timepoint(s) of evaluation of this end point: Visit 1: Within 8 days after inclusion, during the acute phase of delirium. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Structural and functional brain abnormalities in patients at V1 and V2 in terms of whole-brain structural-functional disconnects (multimodal MRI) - Cerebral neurotropism of CoV-2-SARS-SRAS at V1 and V2 through the identification of viral quasispecies and characterization of serological profiles related to CoV-2-SARS infection (blood and CSF) - The central and peripheral immune response at V1 and V2 - The evolution of patients and the impact of delirium on the cognitive level thanks to the performance of patients during the simple neurocognitive evaluation at V1 and multidomain evaluation at V2, using global and specific scales of major cognitive functions. ;Timepoint(s) of evaluation of this end point: Visit 1: Within 8 days after inclusion, during the acute phase of delirium. | — |
Countries
France
Contacts
Public ContactDRI
University Hospital of Toulouse
Outcome results
None listed