Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorHôpital le Vinatier
About this trial
The validation of biomarkers allowing the discrimination of cognitive and behavioral disorders of psychiatric origin from those of neurodegenerative origin would facilitate diagnosis and improve patient management. Neurofilaments, which are markers of neuronal lysis, appear to be a promising biomarker. In a previous preliminary study, the investigators demonstrated significantly lower concentrations of neurofilaments in CSF of psychiatric patients compared to neurodegenerative diseases.
The main objective of this study is to validate the plasma assay of neurofilament light chain as a biomarker for the differential diagnosis of psychiatric or neurodegenerative cognitive impairment. Other biomarkers of interest (Tau, TDP-43, GFAP and UCH-L1) will also be analyzed.
A sub-part of this study will also focus on the retrospective analysis of the CSF/Plasma correlations of the different biomarkers mentioned above from tube bottom samples taken in routine care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
haven given written consent
Schizophrenia (DSM-V criteria) with or without cognitive involution
Bipolar disorder (DSM-V criteria) with or without cognitive involution
probable or definite FTD (Rascovsky criteria 2011)
Disqualifiers
Uninterviewable patient and/or missing history
History of recent or previous head trauma with loss of consciousness
History of ischemic or hemorrhagic stroke
Chronic alcoholism / chronic drug use
Trial design
Design model
Parallel
Treatments tested in this trial
blood sample taken
Diagnostic testComparaison of Neurofilament light chain serum concentration between the arms
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Participant with psychiatric condition without cognitive impairmentExperimental treatment 1 intervention
Group B: Participant with psychiatric condition with cognitive impairmentExperimental treatment 1 intervention
Group C: Patients with biological Alzheimer's diseaseExperimental treatment 1 intervention
Group D: Patient with fronto-temporal dementiaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
neurofilament light chain
serum neurofilament light chain concentration
Time frame
two monthsSecondary outcomes
1
Total tau
serum tau protein concentration
Time frame
two months2
GFAP Glial fibrillary acidic protein
Serum GFAP concentration
Time frame
two months3
neurofilament heavy chain (pNF-h)
Serum neurofilament heavy chain (pNF-h) concentration
Time frame
two monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov