Disease Biosignatures in ALS/FTD Spectrum: New Impactful Biological Perspectives Beyond Clinical Approaches

Recruiting now

Conditions studied: ALS (Amyotrophic Lateral Sclerosis), FTD, Neuropathic, Psychiatric Disorders, Idiopathic Intracranial Hypertension, Frontotemporal Dementia (FTD)

In brief

Diagnosis of ALS/FTD disease spectrum is challenging because it largely relies on clinical symptoms. Identifying novel biomarkers is essential for a paradigm shift towards a more precise biological-based diagnosis. To achieve this aim, having access to proper specimens and analytical methods is crucial. Our team of experts in neurology, biology, chemistry, physics, and AI will explore ALS/FTD from novel perspectives using transcriptomics, proteomics, genomics and other innovative approaches to analyzing easily accessible tissues. The seed amplification assay (SAA) will be also exploited to detect pathological TDP-43. This project aims to create disease fingerprints useful for patient stratification and monitoring of disease progression, and to evaluate the therapeutic efficacy in clinical trials, thus overcoming the limits of clinical interpretation. Discovering new biomarkers and cellular pathways will improve the diagnosis and treatment of these devastating diseases.

Key facts

Study ID

NCT06856850

Run by

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

People needed

230

Starts

2025-02-27

Expected to finish

2026-08-01

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical criteria for ALS (Brooks et al., 2000; de Carvalho M., 2008), FTD (GornoTempini et al., 2011; Rascovsky et al., 2011)

You may not qualify if…

• na

Where it is running

• Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (enrolling)
• Università degli Studi di Napoli "Federico II" — Naples, Italy
• Azienda Ospedaliero Universitaria di Sassari — Sassari, Italy
• Consorzio Interuniversitario Risonanze Magnetiche Metallo Proteine (CIRMMP) — Sesto Fiorentino, Italy

Full record on ClinicalTrials.gov

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