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NCT07706270

Serum Neurofilaments in the Diagnosis of Amyotrophic Lateral Sclerosis

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

Summary

Amyotrophic lateral sclerosis (ALS) is a serious neurodegenerative disease, often difficult to diagnose due to symptoms similar to other neurological pathologies. Diagnosis can take up to 14 months, although the rapid progression of the disease requires early detection. At present, there is no validated biomarker to aid diagnosis. Serum neurofilaments light chain (NfL), markers of neuronal degeneration, show great potential to help diagnose ALS early and assess disease severity. Recent research has shown that measurement of NfL in the blood can differentiate ALS from other neurological disorders, and new technologies are increasingly making it possible to perform these tests clinically. The study hypothesis is that NfL blood levels, measured using clinical analyzers, could improve early ALS diagnosis, optimize patient recruitment for therapeutic trials and accelerate the assessment of treatment efficacy. The primary objective is to evaluate the sensitivity and specificity of serum NfL for the diagnosis and differential diagnosis of amyotrophic lateral sclerosis (ALS) in newly recruited patients referred to the ALS Reference Center at Montpellier University Hospital. The diagnosis is established according to the revised El Escorial diagnostic criteria (see Appendix). This diagnosis is determined independently of the serum NfL concentration.

Official title: Diagnostic Performance of Serum Neurofilaments in the Differential Diagnosis of Amyotrophic Lateral Sclerosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

138

Start Date

2026-08-01

Completion Date

2028-08-01

Last Updated

2026-07-20

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Serum Neurofilament Serum NfL Measurement

The procedure involves taking an additional 6 ml blood sample (dry tube) during the first visit, in addition to the routine sample taken for diagnostic investigations. Serum levels of neurofilament light chain (NfL), a biomarker of neuronal damage, will be measured using ultrasensitive techniques (SIMOA, Lumipulse, Cobas). The aim is to assess the diagnostic performance of NfL levels in differentiating ALS from other neurodegenerative diseases, as well as their prognostic value in terms of survival and disease progression.