Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

Not Applicable

Recruiting

• Conditions: Schizophrenia; FTD; Bipolar Disorder; Alzheimer Disease
• Interventions: Diagnostic Test: blood sample taken

• Registration Number: NCT04946916
• Lead Sponsor: Hôpital le Vinatier

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.

Study Timeline

• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-07-01
• Study Start: 2021-10-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08
• Primary Completion: 2024-10-22
• Study Completion: 2025-10-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with biological Alzheimer's disease	blood sample taken	Alzheimer's disease with frontal, amnestic, language, and visual presentation with typical Alzheimer CSF according to the 2011 NIA-AA diagnostic criteria.
Participant with psychiatric condition without cognitive impairment	blood sample taken	In the psychiatric condition group without cognitive impairment will be included participants with schizophrenia or bipolar disorder according to DSM V criteria.
Participant with psychiatric condition with cognitive impairment	blood sample taken	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.
Patient with fronto-temporal dementia	blood sample taken	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.

Primary Outcome Measures

Name	Time	Method
neurofilament light chain	two months	serum neurofilament light chain concentration

Secondary Outcome Measures

Name	Time	Method
neurofilament heavy chain (pNF-h)	two months	Serum neurofilament heavy chain (pNF-h) concentration
Total tau	two months	serum tau protein concentration
GFAP Glial fibrillary acidic protein	two months	Serum GFAP concentration

Trial Locations

Locations (2)

Centre Hospitalier Le Vinatier; 🇫🇷 Bron Cedex, France

HCL Consultation mémoire Neurologique -Hôpital Neurologique; 🇫🇷 Bron, France