DIAGALS: Relation Between Tar DNA Binding Protein(TDP)-43 et Nrf-2 in ALS: a Track to Improve Diagnosis and Prognosis of the Disease

NCT ID: NCT06230562

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2025-08-31

Brief Summary

In response to oxidative stress, cells activate the Nrf-2 pathway, which induces translation of its target genes and corresponding proteins involved in the antioxidant response. This explains the interest in the Nrf-2 pathway in the pathophysiology of Amyotrophic lateral sclerosis (ALS), supported by the results of several studies and the modulatory effect of TDP-43 on the Nrf-2 pathway. Since both TDP-43 and Nrf-2 proteins are present in the peripheral blood mononuclear cells (PBMC) of ALS patients and may be correlated with disease progression, the investigators wish to explore their relationship and their application in the clinic as potential blood biomarkers for ALS.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Case group

Group Type: EXPERIMENTAL

Blood sample

Intervention Type: BIOLOGICAL

The intervention is to take a blood sample every 6 months for 1 year which is not part of health routine care

Control group

Group Type: ACTIVE_COMPARATOR

Blood sample

Intervention Type: BIOLOGICAL

The intervention is to take a blood sample at baseline.

Interventions

Blood sample

The intervention is to take a blood sample every 6 months for 1 year which is not part of health routine care

Intervention Type: BIOLOGICAL

Blood sample

The intervention is to take a blood sample at baseline.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Men and women ≥ 18 years old
• Person affiliated to a French social security scheme or equivalent
• ALS diagnosed according to El Escorial criteria
• Diagnosis of ALS < 6 months
• Onset of symptoms < 2 years
• Signed informed consent

• Pregnant or breast-feeding
• Treatment with oral or injectable anticoagulants, antiplatelet agents (EXCEPT aspirin at the maximum authorized dosage of 160 mg per day)
• Unbalanced diabetes
• Long-term corticosteroid therapy
• Persons deprived of their liberty by judicial or administrative decision; Persons under legal protection: guardianship or curators
• Genetic mutations associated with ALS

Control group :

• Male or female volunteer aged 18 or over
• Person affiliated to a French social security scheme or equivalent
• Signed informed consent

• Pregnant or breast-feeding women
• Treatment with oral or injectable anticoagulants, antiplatelet agents (except aspirin at the maximum authorized dosage of 160 mg per day)
• Unbalanced diabetes
• Long-term corticosteroid therapy
• Neurological diseases
• Patient under legal protection (safeguard of justice, curators and guardianship), or in a situation of deprivation of liberty
• Genetic mutations associated with ALS

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Elodie Mousset

Role: CONTACT

e.mousset@chu-tours.fr

+33247474665

Other Identifiers

DR230136

Identifier Type: -

Identifier Source: org_study_id