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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Centre Hospitalier Le Vinatier
RECRUITING
Bron
HCL Consultation mémoire Neurologique -Hôpital Neurologique
RECRUITING
Bron
Contact Information
Primary
Dorey Jean-Michel, MD,PHD
jean-michel.dorey@ch-le-vinatier.fr
0437915249
Backup
SARTELET lydie
lydie.sartelet@ch-le-vinatier.fr
0437915531
Time Frame
Start Date: 2021-10-22
Estimated Completion Date: 2028-03-22
Participants
Target number of participants: 120
Treatments
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.
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.
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.
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.
Sponsors
Leads: Hôpital le Vinatier

This content was sourced from clinicaltrials.gov