Using neurofilament light chains to differentiate cognitive impairments in psychiatric and neurodegenerative diseases
Validation of Serum Neurofilament Light Chain as a Biomarker to Differentiate Cognitive Impairment From Neurodegenerative or Psychiatric Diseases
This study is testing if a specific protein in the blood can help tell the difference between cognitive problems caused by mental health issues and those caused by brain diseases like Alzheimer's or dementia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Hôpital le Vinatier Academic / other |
| Locations | 2 sites (Bron and 1 other locations) |
| Trial ID | NCT04946916 on ClinicalTrials.gov |
What this trial studies
This study aims to validate neurofilament light chains as a biomarker for distinguishing cognitive and behavioral disorders of psychiatric origin from those of neurodegenerative origin. It will include 120 participants, divided into groups based on their diagnoses of schizophrenia, bipolar disorder, Alzheimer's disease, or frontotemporal dementia. Participants will undergo cognitive, behavioral, and psychiatric evaluations, along with blood sample collection for biomarker analysis. The study also includes a retrospective analysis of correlations between biomarkers in cerebrospinal fluid and plasma samples.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 45 to 80 with diagnosed schizophrenia, bipolar disorder, Alzheimer's disease, or frontotemporal dementia.
Not a fit: Patients with recent head trauma, severe metabolic disorders, or those outside the age range of 45 to 80 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and management of cognitive impairments in patients with psychiatric and neurodegenerative diseases.
How similar studies have performed: Previous studies have shown promise in using neurofilaments as biomarkers, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bron and 1 other locations
- HCL Consultation mémoire Neurologique -Hôpital Neurologique — Bron, France (Recruiting)
- Centre Hospitalier Le Vinatier — Bron, France (Recruiting)
Study contacts
- Principal investigator: Jean-Michel DOREY, MD, PHD — CH le Vinatier
- Study coordinator: Dorey Jean-Michel, MD,PHD
- Email: jean-michel.dorey@ch-le-vinatier.fr
- Phone: 0437915249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.