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Serum Neurofilaments in the Diagnosis of Amyotrophic Lateral Sclerosis

NCT07706270 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2026-07-20

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Elisa DE LA CRUZ, MD · University Hospital, Montpellier

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-08-01
Completion
2028-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07706270 on ClinicalTrials.gov