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

  • End date
    Oct 22, 2025
  • participants needed
  • sponsor
    Hôpital le Vinatier
Updated on 21 October 2022
cognitive impairment
bipolar disorder
alzheimer's disease


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.


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.

Condition Schizophrenia, Bipolar Disorder, Alzheimer Disease, FTD
Treatment Blood sample taken
Clinical Study IdentifierNCT04946916
SponsorHôpital le Vinatier
Last Modified on21 October 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note