SchizophreniaNfl_COGNCT04946916
Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease
A study testing blood sample taken in people with Schizophrenia and Bipolar Disorder, run by Hôpital le Vinatier at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Alzheimer Disease
- What is being tested?
- blood sample taken
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Oct 2021to 22 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
HCL Consultation mémoire Neurologique -Hôpital Neurologique
Bron, 69677
Maïté Formaglio, PH, 04.72.35.76.62 ext. +33, maite.formaglio@chu-lyon.fr
- Recruiting
Centre Hospitalier Le Vinatier
Bron, 69678
Jean-Michel DOREY, MD, PHD, 04 37 91 51 00, jean-michel.dorey@ch-le-vinatier.fr
Jean-Michel DOREY, md, PHD
About this study
Official title: Validation of Serum Neurofilament Light Chain as a Biomarker to Differentiate Cognitive Impairment From Neurodegenerative or Psychiatric Diseases
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.
Read the 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.
- Conditions
- Schizophrenia, Bipolar Disorder, Alzheimer Disease, FTD
- Being tested
- blood sample taken
- Keywords
- dementia, biomarker
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample takenDiagnostic test
Also called Cognitive tests and psychiatric questionnaires
Comparaison of Neurofilament light chain serum concentration between the arms
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: blood sample taken |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurofilament light chain
serum neurofilament light chain concentration
Measured: two months
Secondary outcomes (3)
Total tau
serum tau protein concentration
Measured: two months
GFAP Glial fibrillary acidic protein
Serum GFAP concentration
Measured: two months
neurofilament heavy chain (pNF-h)
Serum neurofilament heavy chain (pNF-h) concentration
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start22 Oct 2021
- Primary completion22 Mar 2027 (estimated)
- Study completion22 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel DOREY, MD, PHD, Principal investigator, CH le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946916
- Sponsor's protocol ID
- 2020-A00695-34
- Acronym
- Nfl_COG
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2021
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical and biological IPD
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Serum Neurofilament Light Chain as a Biomarker to Differentiate Cognitive Impairment From Neurodegenerative or Psychiatric Diseases
- ClinicalTrials.gov ID
- NCT04946916
- Acronym / sponsor ID
- Nfl_COG / 2020-A00695-34
- Conditions
- Schizophrenia, Bipolar Disorder, Alzheimer Disease, FTD
- Keywords
- dementia, biomarker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 22 Mar 2027 (estimated)
- Study completion
- 22 Mar 2028 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Participant with psychiatric condition without cognitive impairment | Experimental | Diagnostic Test: blood sample takenIn 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 | Experimental | Diagnostic Test: blood sample takenIn 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. |
| Patients with biological Alzheimer's disease | Experimental | Diagnostic Test: blood sample takenAlzheimer's disease with frontal, amnestic, language, and visual presentation with typical Alzheimer CSF according to the 2011 NIA-AA diagnostic criteria. |
| Patient with fronto-temporal dementia | Experimental | Diagnostic Test: blood sample takenProbable 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- haven given written consent
- Schizophrenia (DSM-V criteria) with or without cognitive involution
- Bipolar disorder (DSM-V criteria) with or without cognitive involution
- probable or definite FTD (Rascovsky criteria 2011)
- Biological Alzheimer's disease with typical CSF (NIA-AA 2011)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample takenAlso: Cognitive tests and psychiatric questionnairesComparaison of Neurofilament light chain serum concentration between the arms | Diagnostic test | Participant with psychiatric condition with cognitive impairment, Participant with psychiatric condition without cognitive impairment, Patient with fronto-temporal dementia, Patients with biological Alzheimer's disease |
Primary outcome
neurofilament light chain
Time frame: two months
serum neurofilament light chain concentration
3 secondary outcomes
Total tau
Time frame: two months
GFAP Glial fibrillary acidic protein
Time frame: two months
neurofilament heavy chain (pNF-h)
Time frame: two months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Yes. Clinical and biological IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Michel DOREY, MD, PHD principal investigator
CH le Vinatier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample taken in people with Schizophrenia and Bipolar Disorder, run by Hôpital le Vinatier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorey Jean-Michel, MD,PHD (0437915249 ext. +33, jean-michel.dorey@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neurofilament light chain (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.