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Clinical Trials in France / NCT04946916
Recruiting Not applicable

Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

NCT04946916 · tracked via the Priya Life Science France tracker
Sponsor
Hôpital le Vinatier
Phase
Not applicable
Started
2021-10-22
Last updated
2025-07-24

Condition(s) studied

SchizophreniaBipolar DisorderAlzheimer DiseaseFTD

Investigational drug(s) / intervention(s)

blood sample taken

blood sample taken: Comparaison of Neurofilament light chain serum concentration between the arms

Study summary

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

Sex
ALL
Min age
45 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * haven given written consent Participants with psychiatric conditions: * Schizophrenia (DSM-V criteria) with or without cognitive involution * Bipolar disorder (DSM-V criteria) with or without cognitive involution Participants with neurodegenerative disease: * probable or definite FTD (Rascovsky criteria 2011) * Biological Alzheimer's disease with typical CSF (NIA-AA 2011) Exclusion Criteria: * 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 * Progressive somatic pathology / severe metabolic disorder / poorly controlled epilepsy * Age \< 45 years * Age \> 80 years * Electroconvulsive therapy for less than 6 months

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
HCL Consultation mémoire Neurologique -Hôpital Neurologique Bron France Recruiting
Centre Hospitalier Le Vinatier Bron France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04946916 on ClinicalTrials.gov ↗ ← All trials in France