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Recruiting NCT04946916

Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

No phase Interventional Schizophrenia Bipolar Disorder Alzheimer Disease FTD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood sample taken.
Who it may be relevant to
Registry conditions: Schizophrenia, Bipolar Disorder, Alzheimer Disease, FTD. Basic parameters: 45 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • neurofilament light chain [Time frame: two months]
Secondary outcome measures (3)
  • Total tau [Time frame: two months]
  • GFAP Glial fibrillary acidic protein [Time frame: two months]
  • neurofilament heavy chain (pNF-h) [Time frame: two months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 2 centers
  • HCL Consultation mémoire Neurologique -Hôpital Neurologique — Bron
  • Centre Hospitalier Le Vinatier — Bron

Identifiers

NCT: NCT04946916 · 2020-A00695-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗