Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease (Nfl_COG)

October 3, 2022 updated by: Hôpital le Vinatier

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69677
        • Recruiting
        • HCL Consultation mémoire Neurologique -Hôpital Neurologique
        • Contact:
      • Bron Cedex, France, 69678
        • Recruiting
        • Centre Hospitalier Le Vinatier
        • Contact:
        • Principal Investigator:
          • Jean-Michel DOREY, md, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participant with psychiatric condition without cognitive impairment
In the psychiatric condition group without cognitive impairment will be included participants with schizophrenia or bipolar disorder according to DSM V criteria.
Diagnostic test: blood sample taken
Comparaison of Neurofilament light chain serum concentration between the arms
Other Names:
  • Cognitive tests and psychiatric questionnaires
Experimental: Participant with psychiatric condition with cognitive impairment
In the psychiatric condition group with cognitive impairment will be included participants with schizophrenia or bipolar disorder according to DSM V criteria. To date, there are no clinical criteria for defining the dementia evolution of psychiatric disorders. The diagnosis of psychiatric disorder with cognitive involution is often made on the basis of subjective criteria or on the appreciation of health care teams. In the present study, cognitive involution will be defined by the occurrence of cognitive deterioration objectified by disturbed neuropsychological tests and the occurrence of progressive behavioral changes contrasting with the person's previous state and reported by the care team, a member of the family or by the patient himself. Cognitive involution must be accompanied by a decrease in autonomy with respect to the person's previous abilities.
Diagnostic test: blood sample taken
Comparaison of Neurofilament light chain serum concentration between the arms
Other Names:
  • Cognitive tests and psychiatric questionnaires
Experimental: Patients with biological Alzheimer's disease
Alzheimer's disease with frontal, amnestic, language, and visual presentation with typical Alzheimer CSF according to the 2011 NIA-AA diagnostic criteria.
Diagnostic test: blood sample taken
Comparaison of Neurofilament light chain serum concentration between the arms
Other Names:
  • Cognitive tests and psychiatric questionnaires
Experimental: Patient with fronto-temporal dementia
Probable or definite Fronto-temporal dementia, mostly behavioral variant of FTD (according to the diagnostic criteria for FTDb of Rascovsky, 2011) but Semantic Disease, Primary Progressive Non-Fluent Aphasia, Progressive Supra-Nuclear Palsy-DFT will be accepted if behavioral onset.
Diagnostic test: blood sample taken
Comparaison of Neurofilament light chain serum concentration between the arms
Other Names:
  • Cognitive tests and psychiatric questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neurofilament light chain
Time Frame: two months
serum neurofilament light chain concentration
two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total tau
Time Frame: two months
serum tau protein concentration
two months
GFAP Glial fibrillary acidic protein
Time Frame: two months
Serum GFAP concentration
two months
neurofilament heavy chain (pNF-h)
Time Frame: two months
Serum neurofilament heavy chain (pNF-h) concentration
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital le Vinatier

Investigators

  • Principal Investigator: Jean-Michel DOREY, MD, PHD, CH Le Vinatier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2021

Primary Completion (Anticipated)

October 22, 2024

Study Completion (Anticipated)

October 22, 2025

Study Registration Dates

First Submitted

June 23, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

July 1, 2021

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00695-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Clinical and biological IPD

IPD Sharing Time Frame

4 years

IPD Sharing Access Criteria

all criterias

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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