NCT04946916 · RECRUITING

Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease

This study is testing whether a simple blood test measuring a protein called neurofilament light chain (NfL) can help doctors tell apart cognitive decline caused by psychiatric conditions like schizophrenia or bipolar disorder from cognitive decline caused by neurodegenerative diseases like Alzheimer's or FTD. It is not a drug trial — it is a diagnostic study, meaning researchers are evaluating a biomarker, not testing a treatment.

Eligibility 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

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-07-24

View full record on ClinicalTrials.gov

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