NCT04946916

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
23mo left

Started Oct 2021

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Oct 2021Mar 2028

First Submitted

Initial submission to the registry

June 23, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 22, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2028

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

5.4 years

First QC Date

June 23, 2021

Last Update Submit

July 23, 2025

Conditions

SchizophreniaBipolar DisorderAlzheimer DiseaseFTD

Keywords

dementiabiomarker

Outcome Measures

Primary Outcomes (1)

  • neurofilament light chain

    serum neurofilament light chain concentration

    two months

Secondary Outcomes (3)

  • Total tau

    two months

  • GFAP Glial fibrillary acidic protein

    two months

  • neurofilament heavy chain (pNF-h)

    two months

Study Arms (4)

Participant with psychiatric condition without cognitive impairment

EXPERIMENTAL

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

Diagnostic Test: blood sample taken

Participant with psychiatric condition with cognitive impairment

EXPERIMENTAL

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.

Diagnostic Test: blood sample taken

Patients with biological Alzheimer's disease

EXPERIMENTAL

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

Diagnostic Test: blood sample taken

Patient with fronto-temporal dementia

EXPERIMENTAL

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.

Diagnostic Test: blood sample taken

Interventions

blood sample takenDIAGNOSTIC_TEST

Comparaison of Neurofilament light chain serum concentration between the arms

Also known as: Cognitive tests and psychiatric questionnaires
Participant with psychiatric condition with cognitive impairmentParticipant with psychiatric condition without cognitive impairmentPatient with fronto-temporal dementiaPatients with biological Alzheimer's disease

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HCL Consultation mémoire Neurologique -Hôpital Neurologique

Bron, 69677, France

RECRUITING

Centre Hospitalier Le Vinatier

Bron, 69678, France

RECRUITING

MeSH Terms

Conditions

SchizophreniaBipolar DisorderAlzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive Disorders

Study Officials

  • Jean-Michel DOREY, MD, PHD

    CH le Vinatier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorey Jean-Michel, MD,PHD

CONTACT

0437915249jean-michel.dorey@ch-le-vinatier.fr

SARTELET lydie

CONTACT

0437915531lydie.sartelet@ch-le-vinatier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 1, 2021

Study Start

October 22, 2021

Primary Completion (Estimated)

March 22, 2027

Study Completion (Estimated)

March 22, 2028

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Clinical and biological IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
4 years
Access Criteria
all criterias

Locations

FR(2)