Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

Schizophrenia Clinical Trial

— Nfl_COG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04946916
• Other study ID #: 2020-A00695-34
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: October 22, 2025

Study information

• Verified date: October 2022
• Source: Hôpital le Vinatier
• Contact: Dorey Jean-Michel, MD,PHD
• Phone: 0437915249
• Email: jean-michel.dorey[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 22, 2025
• Est. primary completion date: October 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Bipolar Disorder
• Cognitive Dysfunction
• FTD
• Mental Disorders
• Schizophrenia

Intervention

Diagnostic Test:
• blood sample taken
Comparaison of Neurofilament light chain serum concentration between the arms

Locations

Country	Name	City	State
France	HCL Consultation mémoire Neurologique -Hôpital Neurologique	Bron
France	Centre Hospitalier Le Vinatier	Bron Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurofilament light chain	serum neurofilament light chain concentration	two months
Secondary	Total tau	serum tau protein concentration	two months
Secondary	GFAP Glial fibrillary acidic protein	Serum GFAP concentration	two months
Secondary	neurofilament heavy chain (pNF-h)	Serum neurofilament heavy chain (pNF-h) concentration	two months