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NCT03088839

Circulating Biomarker for Amyotrophic Lateral Sclerosis (ALS)

Status unknown Last updated 15 March 2023
What this trial tests

trial in Amyotrophic Lateral Sclerosis (ALS) in 60 participants. Status unknown.

Timeline
1 December 2017
Primary endpoint
1 September 2023
1 December 2024

Quick facts

Lead sponsorNeuromed IRCCS
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment60
Start date1 December 2017
Primary completion1 September 2023
Estimated completion1 December 2024
Sites1 location across Italy

Conditions studied

Sponsor

Neuromed IRCCS

Who can join

Adults 20 to 75, any sex, with Amyotrophic Lateral Sclerosis (ALS). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Amyotrophic Lateral Sclerosis (ALS) is a rare disease with a worldwide incidence of 2-3 cases per 100,000 individuals/year and it is characterized by progressive neurodegeneration of motor neurons. When motor neurons degenerate the ability of the brain to initiate and control muscle movement is lost. ALS manifests in two forms: Familiar ALS (FALS) with inherited risk genotypes, accounts for only 10% of cases and sporadic ALS (SALS) without apparent heritability accounts for 90% of cases. ALS can occur in both female and male subjects at any age but is more common in people aged over 40. Although the molecular mechanism underlying the pathogenesis of ALS is still under investigation, recent research has revealed that diseases affecting motor neurons may be associated to alterations of RNA metabolism and biogenesis of small non-coding micro RNAs (miRNAs). miRNAs are circulating molecules, whose expression profiles are widely described to have an important potential in monitoring the progression of a disease, to promote the development of more targeted therapies and/or to determine the effectiveness of treatments. Altered patterns of specific miRNAs expression have been described in several pathological conditions. Evidence shows a significant reduction in the levels of certain miRNAs also in patients with ALS. Among others, miRNA-218 has been described to play a critical role in the onset of motor neurons differentiation and in establishing cell identity and fate. Changes in the levels of miRNA-218 in the serum of ALS patients may potentially provide useful tools to determine the possible association with this disease and to candidate it as indicator of disease progression.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Fluid biomarkers for amyotrophic lateral sclerosis: a review.
    Irwin KE, Sheth U, Wong PC, Gendron TF. · · 2024 · cited 59× · PMID 38267984 · DOI 10.1186/s13024-023-00685-6
  2. Mechanism and Therapeutic Prospect of miRNAs in Neurodegenerative Diseases.
    Ma YM, Zhao L. · · 2023 · cited 14× · PMID 38058356 · DOI 10.1155/2023/8537296
  3. Clinical Trials of Non-Coding RNAs as Diagnostic and Therapeutic Biomarkers for Central Nervous System Injuries.
    Wang H, Wang Q, Xiao X, Luo X, et al · · 2023 · PMID 36443964 · DOI 10.2174/1570159x21666221128090025

Verify or expand the search:

Other recruiting trials for Amyotrophic Lateral Sclerosis (ALS)

Currently open trials in the same condition.

Other Neuromed IRCCS trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03088839.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing