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NCT Number: NCT04946916

Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

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.

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Key information

Conditions

Schizophrenia Alzheimer Disease Bipolar Disorder Bipolar and Related Disorders Brain Diseases Central Nervous System Diseases Dementia FTD Mental Disorders Mood Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Schizophrenia Spectrum and Other Psychotic Disorders Tauopathies

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Le Vinatier, Bron, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample taken

Diagnostic Test

Comparaison of Neurofilament light chain serum concentration between the arms

Other names: Cognitive tests and psychiatric questionnaires

Primary outcomes

  1. neurofilament light chain

    Time frame: two months

    serum neurofilament light chain concentration

Secondary outcomes

  1. Total tau

    Time frame: two months

    serum tau protein concentration

  2. GFAP Glial fibrillary acidic protein

    Time frame: two months

    Serum GFAP concentration

  3. neurofilament heavy chain (pNF-h)

    Time frame: two months

    Serum neurofilament heavy chain (pNF-h) concentration

Study contacts

Contact information is provided by the study sponsor or research team.

Dorey Jean-Michel, MD,PHD

CONTACT

[email protected]

0437915249 ext. +33

SARTELET lydie

CONTACT

[email protected]

0437915531 ext. +33

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

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

Acronym: Nfl_COG

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Jul 1, 2021
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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