Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Auxologico Italiano
About this trial
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
This trial does not accept healthy volunteersQualifiers
diagnosis of ALS or other motor neuron disease
residence near the study centers
Disqualifiers
refusal to participate to the study
unable/unwilling to perform follow-up visits
Trial population
Consecutive cohort of incident patients from three Italian ALS Centers
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
genetic screening
no. of patients with ALS-associated mutations
Time frame
baseline (at diagnosis)2
biomarker assessment
no. of patients with abnormal NfL, GFAP, tau, UCHL1, MCP1 and TDP-43 levels
Time frame
baseline (at diagnosis), at 6 months, at 1 yearSecondary outcomes
1
clinical assessment
no. of patients with increasing vs decreasing PUMNS/LMNS scores
Time frame
baseline (at diagnosis), at 6 months, at 1 year2
neuropsychological assessment
no. of patients with increasing vs decreasing ECAS scores
Time frame
baseline (at diagnosis), at 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituto Auxologico Italiano
Lead sponsor
A.O.U. Città della Salute e della Scienza
Collaborator
Ospedale San Raffaele
Collaborator
Source ClinicalTrials.gov