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Neurofilament Assay for the Diagnosis of ALS

Contribution of the Neurofilament Assay for the Diagnosis of ALS (Amyotrophic Lateral Sclerosis) in Situations of Diagnostic Standoff After Evaluation in an Expert ALS Center

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05077696
Acronym
FILSLAN-NF
Enrollment
100
Registered
2021-10-14
Start date
2021-11-01
Completion date
2023-11-01
Last updated
2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progressive Motor Neuron Disease Without Definite Diagnosis

Keywords

ALS, Neurofilaments, NFL, pNFH, Amyotrophic Lateral Sclerosis, progressive motor neuron disease

Brief summary

The aim of the study is to evaluate the interest of the determination of pNFH and NFL neurofilaments in serum for the diagnosis of ALS in patients with a diagnostic standoff after evaluation in an expert ALS center. The hypothesis is that one of these biomarkers, or their combined analysis, will make it possible to confirm or invalidate the diagnosis of ALS.

Detailed description

For this study, which aims to evaluate a test to help in the diagnosis of ALS that could be integrated into routine practice, it was preferred to use blood tests. Blood sampling is significantly less invasive than CSF sampling, and more easily generalized, including in ambulatory conditions.

Interventions

OTHERDrawing a tube of blood (serum)

dosage of neurofilaments and comparison with a final diagnosis one year after sampling.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

: Subjects with first and/or second motor neuron disease, evolving clinically and/or electrically over at least 12 months, not meeting the diagnostic criteria for ALS (revised El Escorial criteria): * Isolated peripheral motor neuron disease (at least one region of the PNM) OR * Isolated central motor neuron involvement (at least two areas of the MNC) OR * associated involvement of the MNP and MNC but in the presence of an associated pathology responsible for a persistent diagnostic doubt (double narrow cervical and lumbar canal, associated evolving cancer evoking a paraneoplastic syndrome without specific antibody found) Age superior to 18 years Management and follow-up in one of the French ALS centers Patient able to express his non-opposition Affiliation with social security or beneficiary of such a plan Non-inclusion criteria: Refusal of the patient Person under a legal protection measure (guardianship, curatorship or safeguard of justice). Person deprived of liberty by judicial or administrative decision.

Design outcomes

Primary

MeasureTime frameDescription
contribution of pNFH and NFL neurofilaments assays1 yearcontribution of pNFH and NFL neurofilaments assays in serum for the positive diagnosis of ALS in a selected population of patients with progressive motor neuron disease without definite diagnosis

Secondary

MeasureTime frameDescription
Value of the combined pNFH and NFL neurofilament assay in serum versus the pNFH and NFL assay alone1 yearTo evaluate the value of the combined pNFH and NFL neurofilament assay in serum versus the pNFH and NFL assay alone for the positive diagnosis of ALS in a selected population of patients with progressive motor neuron disease without a definite diagnosis.

Contacts

Primary ContactMaria del Mar Amador
mariadelmar.amador@aphp.fr1 42 16 24 72

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026