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Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis
NCT06318598 · Istituto Auxologico Italiano
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Dissezione Fenotipica Guidata da Biomarcatori Della Sclerosi Laterale Amiotrofica/Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis
About this study
The goal of this observational study is to understand the clinical variability in a population of ALS patients using multidimensional biomarkers. The main questions it aims to answer are:
* Which set of biomarkers explain genotypic-phenotypic correlations in ALS?
* Which set of biomarkers can be used to subdivide the ALS population in homogeneous subgroups?
Participants will undergo:
* neurological evaluation
* neurophysiological evaluation
* neuropsychological evaluation
* whole exome sequencing
* biomarker measurement in CSF and plasma
Eligibility criteria
Inclusion Criteria:
* diagnosis of ALS or other motor neuron disease
* residence near the study centers
Exclusion Criteria:
* refusal to participate to the study
* unable/unwilling to perform follow-up visits
Study design
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-04-11
Estimated completion: 2026-04-10
Last updated: 2025-05-07
Primary outcomes
- • genetic screening (baseline (at diagnosis))
- • biomarker assessment (baseline (at diagnosis), at 6 months, at 1 year)
Sponsor
Istituto Auxologico Italiano · other
With: A.O.U. Città della Salute e della Scienza, Ospedale San Raffaele
Contacts & investigators
ContactNicola Ticozzi, MD, PhD · contact · n.ticozzi@auxologico.it · +390261911
All locations (3)
Ospedale San RaffaeleRecruiting
Milan, MI, Italy
Ospedale San LucaRecruiting
Milan, MI, Italy
AOU Città della Salute e della ScienzaRecruiting
Torino, TO, Italy