NCT04946916Recruiting
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
Source: ClinicalTrials.gov · Last updated 24 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 23 Jun 2021
- Start date
- 22 Oct 2021
- Primary completion date
- 22 Mar 2027
- Lead sponsor
- Hôpital le Vinatier
- Diseases
- Schizophrenia, Bipolar disorder, Alzheimer disease
- NCT number
- NCT04946916
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 22 Oct 2021 to the primary completion date, 22 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of recent or previous head trauma with loss of consciousness
- Chronic alcoholism / chronic drug use
- Electroconvulsive therapy for less than 6 months
Other illness
- History of ischemic or hemorrhagic stroke
- Progressive somatic pathology / severe metabolic disorder / poorly controlled epilepsy
Age
- Age \< 45 years
- Age \> 80 years
Other
- Uninterviewable patient and/or missing history
Who the study is looking for
- 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)
Age in the registry: 45 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Le Vinatier Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| HCL Consultation mémoire Neurologique -Hôpital Neurologique Coordinator of this site? Confirm its status | Bron | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.