Actively Recruiting

Phase Not Applicable
Age: 45Years - 80Years
All Genders
NCT04946916

Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

Led by Hôpital le Vinatier · Updated on 2025-07-24

120

Participants Needed

2

Research Sites

334 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

Who Can Participate

Age: 45Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided written consent
  • Diagnosed with schizophrenia according to DSM-V criteria, with or without cognitive impairment
  • Diagnosed with bipolar disorder according to DSM-V criteria, with or without cognitive impairment
  • Diagnosed with probable or definite frontotemporal dementia according to Rascovsky criteria 2011
  • Diagnosed with biological Alzheimer's disease with typical cerebrospinal fluid profile according to NIA-AA 2011
Not Eligible

You will not qualify if you...

  • Unable to be interviewed or missing medical history
  • History of recent or past head trauma with loss of consciousness
  • History of ischemic or hemorrhagic stroke
  • Chronic alcoholism or chronic drug use
  • Progressive somatic illness, severe metabolic disorder, or poorly controlled epilepsy
  • Age younger than 45 years
  • Age older than 80 years
  • Electroconvulsive therapy within the past 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

HCL Consultation mémoire Neurologique -Hôpital Neurologique

Bron, France, 69677

Actively Recruiting

2

Centre Hospitalier Le Vinatier

Bron, France, 69678

Actively Recruiting

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Research Team

D

Dorey Jean-Michel, MD,PHD

CONTACT

S

SARTELET lydie

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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