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

Primary Purpose

Schizophrenia, Bipolar Disorder, Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample taken
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Schizophrenia focused on measuring dementia, biomarker

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Le VinatierRecruiting
  • HCL Consultation mémoire Neurologique -Hôpital NeurologiqueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Participant with psychiatric condition without cognitive impairment

Participant with psychiatric condition with cognitive impairment

Patients with biological Alzheimer's disease

Patient with fronto-temporal dementia

Arm Description

In the psychiatric condition group without cognitive impairment will be included participants with schizophrenia or bipolar disorder according to DSM V criteria.

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.

Alzheimer's disease with frontal, amnestic, language, and visual presentation with typical Alzheimer CSF according to the 2011 NIA-AA diagnostic criteria.

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.

Outcomes

Primary Outcome Measures

neurofilament light chain
serum neurofilament light chain concentration

Secondary Outcome Measures

Total tau
serum tau protein concentration
GFAP Glial fibrillary acidic protein
Serum GFAP concentration
neurofilament heavy chain (pNF-h)
Serum neurofilament heavy chain (pNF-h) concentration

Full Information

First Posted
June 23, 2021
Last Updated
October 3, 2022
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT04946916
Brief Title
Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease
Acronym
Nfl_COG
Official Title
Validation of Serum Neurofilament Light Chain as a Biomarker to Differentiate Cognitive Impairment From Neurodegenerative or Psychiatric Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
October 22, 2024 (Anticipated)
Study Completion Date
October 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder, Alzheimer Disease, FTD
Keywords
dementia, biomarker

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participant with psychiatric condition without cognitive impairment
Arm Type
Experimental
Arm Description
In the psychiatric condition group without cognitive impairment will be included participants with schizophrenia or bipolar disorder according to DSM V criteria.
Arm Title
Participant with psychiatric condition with cognitive impairment
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients with biological Alzheimer's disease
Arm Type
Experimental
Arm Description
Alzheimer's disease with frontal, amnestic, language, and visual presentation with typical Alzheimer CSF according to the 2011 NIA-AA diagnostic criteria.
Arm Title
Patient with fronto-temporal dementia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
blood sample taken
Other Intervention Name(s)
Cognitive tests and psychiatric questionnaires
Intervention Description
Comparaison of Neurofilament light chain serum concentration between the arms
Primary Outcome Measure Information:
Title
neurofilament light chain
Description
serum neurofilament light chain concentration
Time Frame
two months
Secondary Outcome Measure Information:
Title
Total tau
Description
serum tau protein concentration
Time Frame
two months
Title
GFAP Glial fibrillary acidic protein
Description
Serum GFAP concentration
Time Frame
two months
Title
neurofilament heavy chain (pNF-h)
Description
Serum neurofilament heavy chain (pNF-h) concentration
Time Frame
two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorey Jean-Michel, MD,PHD
Phone
0437915249
Ext
+33
Email
jean-michel.dorey@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
SARTELET lydie
Phone
0437915531
Ext
+33
Email
lydie.sartelet@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel DOREY, MD, PHD
Organizational Affiliation
CH le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Le Vinatier
City
Bron Cedex
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Michel DOREY, MD, PHD
Phone
04 37 91 51 00
Email
jean-michel.dorey@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Jean-Michel DOREY, md, PHD
Facility Name
HCL Consultation mémoire Neurologique -Hôpital Neurologique
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maïté Formaglio, PH
Phone
04.72.35.76.62
Ext
+33
Email
maite.formaglio@chu-lyon.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Clinical and biological IPD
IPD Sharing Time Frame
4 years
IPD Sharing Access Criteria
all criterias

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Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

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