Clinical trial NCT04946916: Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease
Official title: Validation of Serum Neurofilament Light Chain as a Biomarker to Differentiate Cognitive Impairment From Neurodegenerative or Psychiatric Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Alzheimer Disease
FTD
Keywords: dementia
biomarker
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four groups of participants will be recruited: participant with psychiatric condition without cognitive impairment, participants with psychiatric condition with cognitive impairment, participants with biological Alzheimer's disease, and participant with fronto-temporal dementia
Primary purpose: DIAGNOSTIC

Brief 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.

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.

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

Primary outcomes:
measure: neurofilament light chain
timeFrame: two months
Secondary outcomes:
measure: Total tau
timeFrame: two months
measure: GFAP Glial fibrillary acidic protein
timeFrame: two months
measure: neurofilament heavy chain (pNF-h)
timeFrame: two months
Other outcomes:
Locations:
city: Bron Cedex
country: France
facility: Centre Hospitalier Le Vinatier
city: Bron
country: France
facility: HCL Consultation mémoire Neurologique -Hôpital Neurologique
Study officials:
affiliation: CH le Vinatier
name: Jean-Michel DOREY, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: