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Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04946916
Acronym
Nfl_COG
Enrollment
120
Registered
2021-07-01
Start date
2021-10-22
Completion date
2028-03-22
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Bipolar Disorder, FTD, Schizophrenia

Keywords

dementia, biomarker

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTblood sample taken

Comparaison of Neurofilament light chain serum concentration between the arms

Sponsors

Hôpital le Vinatier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Four groups of participants will be recruited: participant with psychiatric condition without cognitive impairment, participants with psychiatric condition with cognitive impairment, participants with biological Alzheimer's disease, and participant with fronto-temporal dementia

Eligibility

Sex/Gender
ALL
Age
45 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
neurofilament light chaintwo monthsserum neurofilament light chain concentration

Secondary

MeasureTime frameDescription
Total tautwo monthsserum tau protein concentration
GFAP Glial fibrillary acidic proteintwo monthsSerum GFAP concentration
neurofilament heavy chain (pNF-h)two monthsSerum neurofilament heavy chain (pNF-h) concentration

Countries

France

Contacts

Primary ContactDorey Jean-Michel, MD,PHD
jean-michel.dorey@ch-le-vinatier.fr0437915249
Backup ContactSARTELET lydie
lydie.sartelet@ch-le-vinatier.fr0437915531

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026