Actively Recruiting
Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis
Led by Istituto Auxologico Italiano · Updated on 2025-05-07
200
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Istituto Auxologico Italiano
Lead Sponsor
A
A.O.U. Città della Salute e della Scienza
Collaborating Sponsor
AI-Summary
What this Trial Is About
This observational study focuses on understanding the differences in symptoms and genetics among people with Amyotrophic Lateral Sclerosis (ALS) and other motor neuron diseases. Researchers aim to identify sets of biomarkers that explain how genetic factors relate to symptoms and to categorize patients into more similar groups based on these markers. The study is sponsored by Istituto Auxologico Italiano and seeks to improve knowledge about ALS variability through detailed biomarker analysis. Participants will undergo several evaluations, including neurological, neurophysiological, and neuropsychological tests. Genetic testing through whole exome sequencing will be performed, along with biomarker measurements in cerebrospinal fluid (CSF) and plasma. These assessments will take place at diagnosis, 6 months, and 1 year to track changes over time. During the study, participants will have clinical and neuropsychological assessments at baseline and follow-up points. The main outcomes measured are genetic screening and biomarker levels at diagnosis, 6 months, and 1 year. The study involves no treatment interventions but focuses on collecting detailed data to understand ALS better. Participation requires attending follow-up visits over one year to complete evaluations and provide samples.
CONDITIONS
Brief Title
Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ALS or other motor neuron disease
- Residence near the study centers
You will not qualify if you...
- Refusal to participate in the study
- Unable or unwilling to attend follow-up visits
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At diagnosis
Participants undergo genetic screening and baseline biomarker assessments at diagnosis.
1 visit (in-person)
Duration - 1 year
Participants are monitored with biomarker, clinical, and neuropsychological assessments over one year after diagnosis.
Visits at 6 months and 1 year
Trial Site Locations
Total: 3 locations
1
Ospedale San Raffaele
Milan, MI, Italy, 20132
Actively Recruiting
2
Ospedale San Luca
Milan, MI, Italy, 20149
Actively Recruiting
3
AOU Città della Salute e della Scienza
Torino, TO, Italy, 10126
Actively Recruiting
Research Team
N
Nicola Ticozzi, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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