Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

Recruiting · NCT04946916 · Interventional (participants receive a specific treatment) · Lead sponsor: Hôpital le Vinatier

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Alzheimer's disease Schizophrenia Bipolar Disorder

Interventions studied

blood sample taken

What this trial is about

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.

Who can take part

Age range

45 Years to 80 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

2 locations listed.

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

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →