Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease
NCT ID: NCT04946916
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2021-10-22
2028-03-22
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
blood sample taken
Comparaison of Neurofilament light chain serum concentration between the arms
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.
blood sample taken
Comparaison of Neurofilament light chain serum concentration between the arms
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.
blood sample taken
Comparaison of Neurofilament light chain serum concentration between the arms
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.
blood sample taken
Comparaison of Neurofilament light chain serum concentration between the arms
Interventions
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blood sample taken
Comparaison of Neurofilament light chain serum concentration between the arms
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
45 Years
80 Years
ALL
No
Sponsors
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Hôpital le Vinatier
OTHER
Responsible Party
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Principal Investigators
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Jean-Michel DOREY, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
CH le Vinatier
Locations
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HCL Consultation mémoire Neurologique -Hôpital Neurologique
Bron, , France
Centre Hospitalier Le Vinatier
Bron, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-A00695-34
Identifier Type: -
Identifier Source: org_study_id
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