Neurofilament Assay for the Diagnosis of ALS

• Conditions: Progressive Motor Neuron Disease Without Definite Diagnosis
• Interventions: Other: Drawing a tube of blood (serum)

• Registration Number: NCT05077696
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-01
• Last Update Submitted: 2021-10-01
• Study First Posted: 2021-10-14
• Last Update Posted: 2021-10-14
• Study Start: 2021-11-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with progressive motor neuron disease without definite diagnosis	Drawing a tube of blood (serum)	Patients with progressive motor neuron disease without definite diagnosis

Primary Outcome Measures

Name	Time	Method
contribution of pNFH and NFL neurofilaments assays	1 year	contribution 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 Outcome Measures

Name	Time	Method
Value of the combined pNFH and NFL neurofilament assay in serum versus the pNFH and NFL assay alone	1 year	To 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.