Trials / Recruiting
RecruitingNCT04946916
Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease
Validation of Serum Neurofilament Light Chain as a Biomarker to Differentiate Cognitive Impairment From Neurodegenerative or Psychiatric Diseases
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Hôpital le Vinatier · Academic / Other
- Sex
- All
- Age
- 45 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | blood sample taken | Comparaison of Neurofilament light chain serum concentration between the arms |
Timeline
- Start date
- 2021-10-22
- Primary completion
- 2027-03-22
- Completion
- 2028-03-22
- First posted
- 2021-07-01
- Last updated
- 2025-07-24
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04946916. Inclusion in this directory is not an endorsement.