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Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

Study acronym: Nfl_COG
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Oct 22, 2024 to Mar 22, 2027
    • Study completion date: Oct 22, 2025 to Mar 22, 2028
    v6
  2. 2 versions Re-verified since Oct 3, 2022, no change to tracked fieldsv4-v5
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Oct 1, 2021 to Oct 22, 2024
    • Study sites: 0 to 2
    • Study completion date: Oct 1, 2024 to Oct 22, 2025
    • Start date changed from estimate of Oct 1, 2021 to Oct 22, 2021
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Hôpital le Vinatier
47 trials monitored
See 1 trial at risk
Dementia
1,978 trials monitored
See 106 trials at risk
Alzheimer's Disease
1,253 trials monitored
See 71 trials at risk
Schizophrenia
717 trials monitored
See 35 trials at risk
and 1 more disease
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 Details
NCT Number NCT04946916
Lead Sponsor Hôpital le Vinatier
Conditions
(from sponsor)		 Schizophrenia, Bipolar Disorder, Alzheimer Disease, FTD
Related terms Alzheimer Disease, Bipolar Disorder, Dementia, Schizophrenia
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov