Clinical trial Recruiting at 2 sites Interventional Ages 45 to 80

Using neurofilament light chains to differentiate cognitive impairments in psychiatric and neurodegenerative diseases

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

Run by Hôpital le Vinatier · NCT04946916 · Data updated 2026-11-12

This study is testing if a specific protein in the blood can help tell the difference between cognitive problems caused by mental health issues and those caused by brain diseases like Alzheimer's or dementia.

Quick facts

Study typeInterventional
Ages45 Years to 80 Years
SexAll
Enrollment120 (estimated)
SponsorHôpital le Vinatier
Academic / other
Locations2 sites (Bron and 1 other locations)
StatusRecruiting
StartedOctober 22, 2021
Main results expectedMarch 22, 2027
Study endsMarch 22, 2028
Registry record updatedJuly 24, 2025
Trial IDNCT04946916 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 45 to 80 with diagnosed schizophrenia, bipolar disorder, Alzheimer's disease, or frontotemporal dementia.

Probably not a fit

Patients with recent head trauma, severe metabolic disorders, or those outside the age range of 45 to 80 may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to validate neurofilament light chains as a biomarker for distinguishing cognitive and behavioral disorders of psychiatric origin from those of neurodegenerative origin. It will include 120 participants, divided into groups based on their diagnoses of schizophrenia, bipolar disorder, Alzheimer's disease, or frontotemporal dementia. Participants will undergo cognitive, behavioral, and psychiatric evaluations, along with blood sample collection for biomarker analysis. The study also includes a retrospective analysis of correlations between biomarkers in cerebrospinal fluid and plasma samples.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic accuracy and management of cognitive impairments in patients with psychiatric and neurodegenerative diseases.

How similar studies have gone: Previous studies have shown promise in using neurofilaments as biomarkers, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • HCL Consultation mémoire Neurologique -Hôpital Neurologique
    Bron, France
    Recruiting
  • Centre Hospitalier Le Vinatier
    Bron, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.