Validation of Serum Neurofilament Light Chain as a Biomarker to Differentiate Cognitive Impairment From Neurodegenerative or Psychiatric Diseases (Nfl_COG)

  • STATUS
    Recruiting
  • End date
    Oct 22, 2025
  • participants needed
    120
  • sponsor
    Hôpital le Vinatier
Updated on 21 October 2022
cognitive impairment
bipolar disorder
schizophrenia
alzheimer's disease

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.

Description

One hundred twenty participants will be included in this study

  • 30 participants suffering from psychiatric disorders (bipolar disorder or schizophrenia) without cognitive impairment
  • 30 participants suffering from psychiatric disorders (bipolar disorder or schizophrenia) with cognitive impairment
  • 30 participants with a biological diagnosis of Alzheimer's disease
  • 30 participants with frontotemporal dementia according to Rascosky's criteria

All the participants will perform cognitive, behavioral, and psychiatric evaluation and will be have blood sample taken.

Details
Condition Schizophrenia, Bipolar Disorder, Alzheimer Disease, FTD
Treatment Blood sample taken
Clinical Study IdentifierNCT04946916
SponsorHôpital le Vinatier
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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