Longitudinal integrated biomarker profiling linked to ALS clinical features

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center longitudinal protocol enrolls adults with ALS and neurologic controls to collect serial blood and cerebrospinal fluid samples alongside detailed clinical, genetic, and imaging phenotyping. Primary assays include neurofilament light chain (NfL) and complementary markers such as GFAP, p‑tau181, Aβ42, and Aβ40 measured in CSF and blood to probe different aspects of neurodegeneration and astrocytic activation. Participants undergo lumbar puncture, routine blood chemistry, genetic analysis, and deep phenotyping at baseline and planned follow-ups to map biomarker trajectories against clinical progression. All procedures and follow-up visits are conducted at Istituto Auxologico Italiano IRCCS in Milan to refine prognostic models and improve patient stratification for care and future trials.

Why it matters

Who can join: the full rules

Inclusion Criteria ALS patients:

* diagnosis of Amyotrophic Lateral Sclerosis (ALS);
* age ≥18 y;
* feasibility of lumbar puncture (LP);
* informed consent.

Exclusion Criteria ALS patients:

* severe medical comorbidities;
* recent traumatic, inflammatory, vascular, or neoplastic Central Nervous System disease; contraindications to LP.

Inclusion Criteria Controls:

* age ≥18 y;
* individuals undergoing LP for neurological symptoms;
* no evidence of nervous system pathology;
* informed consent.

Where it's running

• Istituto Auxologico Italiano IRCCS
  Milan, Lombardy, Italy Recruiting

Study contacts

• Study coordinator: Federico Verde, MD
• Email: f.verde@auxologico.it
• Phone: +3902619111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.