Clinical Trial

Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

Study acronym: Nfl_COG
Recruiting
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-06-23; most recent amendment 2025-07-23.
Status change: Not Yet Recruiting → Recruiting 2022-03-23
Trial Details
NCT Number NCT04946916
Lead Sponsor Hôpital le Vinatier
Conditions Schizophrenia, Bipolar Disorder, Alzheimer Disease, FTD
Enrollment 120 participants
Start Date 2021-10-22
Primary Completion 2027-03-22 (estimated)
Study Completion 2028-03-22 (estimated)
Updated on ClinicalTrials.gov 2025-07-24