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NCT Number: NCT07091799

Interest of Measuring P2X4 Receptors on Blood Monocytes as a Diagnostic Marker in Amyotrophic Lateral Sclerosis: P2X4 as a Diagnostic Biomarker for ALS

Amyotrophic lateral sclerosis (ALS) is the most common form of motor neuron disease and is characterized by the degeneration of motor neurons leading to progressive paralysis and death within 3 to 5 years after diagnosis. To date, no key mechanism had been identified. Our associated laboratory has identified the P2X4 purinergic pathway that appears to be involved in the pathogenesis of ALS. Our goal is to verify these results at the human level in order to have a proof of concept of P2X4's role as a biomarker of the disease.

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Key information

Conditions

Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For ALS group: Person presenting a probable or confirmed diagnosis of ALS according to the criteria of EI Escorial.
  • Adult.
  • Person affiliated or beneficiary of a social security scheme.
  • Free, informed and written consent signed by the participant or by a third person (in case of physical incapacity of the participant), after information on the study.

Exclusion criteria

  • People undergoing immunosuppressive or corticosteroid treatments.
  • Participation in a research protocol with an experimental treatment.
  • People placed under guardianship, curatorship or legal protection.
  • For healthy volunteer, people directly related to the patient (siblings, descendants and ancestry).

Treatment and study plan

P2X4 receptors in blood samples

Diagnostic Test

This is an interventional study designed to assay P2X4 receptors in blood samples from ALS patients and healthy volunteers by comparing the mean levels of P2X4 expression.

Primary outcomes

  1. Expression of P2X4 receptor

    Time frame: 6 months after Day 0

    Compare expression of P2X4 receptor in ALS patients versus healthy subjects to demonstrate its role as a clinical biomarker of ALS. Comparison will be obtained by labeling and flow cytometer analysis of circulating monocytes.

Secondary outcomes

  1. Diagnostic performance

    Time frame: 6 months after Day 0

    Evaluate the diagnostic performances of P2X4 receptor assay for the diagnosis of ALS, thanks to sensitivity and specificity of this P2X4 receptor assay

  2. Prognostic performances

    Time frame: 6 months after Day 0

    Evaluate prognostic performances of P2X4 receptor assay for the diagnosis of ALS, thanks to sensitivity and specificity of this P2X4 receptor assay

  3. P2X4 receptor levels evolution

    Time frame: 6 months after Day 0

    Describe evolution of P2X4 receptor levels with a new sample at 6 months in the same patients, thanks to the difference in P2X4 receptor expression average in the same ALS patient

  4. Levels of P2X4 receptors between patients with familial or sporadic ALS.

    Time frame: 6 months after Day 0

    Compare expression levels of P2X4 receptors between patients with familial or sporadic ALS, thanks to the difference in P2X4 receptor expression average

  5. P2X4 receptor levels of patients with a SOD1 mutation treated with anti-SOD1antisense

    Time frame: 6 months after Day 0

    Compare surface P2X4 receptor levels of patients with a SOD1 mutation treated with anti-SOD1 antisense (Qalsody®, TOFERSEN), thanks to the difference in P2X4 receptor expression average

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Fremy

CONTACT

[email protected]

Gwendal Le Masson, Pr

CONTACT

[email protected]

05 57 82 13 70 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: PALS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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