Longitudinal integrated biomarker profiling linked to ALS clinical features
LONgitudinal and Integrated Evaluation of Biomarkers in reLation to phenotYpe in ALS
This project will test whether repeated blood and spinal-fluid biomarker measurements combined with deep clinical profiling can help predict disease course in adults with ALS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT07312240 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with a diagnosis of ALS who can safely undergo lumbar puncture and provide informed consent are ideal candidates.
Not a fit: Patients with severe medical comorbidities, recent traumatic/inflammatory/vascular/neoplastic CNS disease, or contraindications to lumbar puncture are unlikely to be eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, this approach could improve prognostic accuracy and help match patients to the most appropriate treatments or clinical trials.
How similar studies have performed: Neurofilament levels in blood and CSF have consistently correlated with ALS severity and survival, but integrating multiple CSF/blood biomarkers with deep phenotyping is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan, Lombardy
- Istituto Auxologico Italiano IRCCS — Milan, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Federico Verde, MD
- Email: f.verde@auxologico.it
- Phone: +3902619111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.