NCT04946916 Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease
| NCT ID | NCT04946916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hôpital le Vinatier |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-10-22 |
| Primary Completion | 2027-03-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2021-10-22 with a primary completion date of 2027-03-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jean-Michel DOREY, MD, PHD
PRINCIPAL INVESTIGATOR
CH le Vinatier
Frequently Asked Questions
Who can join the NCT04946916 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 80 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04946916 currently recruiting?
Yes, NCT04946916 is actively recruiting participants. Contact the research team at jean-michel.dorey@ch-le-vinatier.fr for enrollment information.
Where is the NCT04946916 trial being conducted?
This trial is being conducted at Bron, France, Bron, France.
Who is sponsoring the NCT04946916 clinical trial?
NCT04946916 is sponsored by Hôpital le Vinatier. The principal investigator is Jean-Michel DOREY, MD, PHD at CH le Vinatier. The trial plans to enroll 120 participants.
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