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NCT06318598 Clinical Trial

Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

— DRIVEALS  

Official title:
Dissezione Fenotipica Guidata da Biomarcatori Della Sclerosi Laterale Amiotrofica/Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06318598
Other study ID # 23M202
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 11, 2023
Est. completion date April 10, 2026

Study information
Verified date March 2024
Source Istituto Auxologico Italiano
Contact Nicola Ticozzi, MD, PhD
Phone +390261911
Email n.ticozzi@auxologico.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date April 10, 2026
Est. primary completion date April 10, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Ospedale San Luca Milano MI
Italy Ospedale San Raffaele Milano MI
Italy AOU Città della Salute e della Scienza Torino TO

Sponsors (3)
Lead Sponsor Collaborator
Istituto Auxologico Italiano Azienda Ospedaliera Città della Salute e della Scienza di Torino, Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary genetic screening no. of patients with ALS-associated mutations baseline (at diagnosis)
Primary biomarker assessment no. of patients with abnormal NfL, GFAP, tau, UCHL1, MCP1 and TDP-43 levels baseline (at diagnosis), at 6 months, at 1 year
Secondary clinical assessment no. of patients with increasing vs decreasing PUMNS/LMNS scores baseline (at diagnosis), at 6 months, at 1 year
Secondary neuropsychological assessment no. of patients with increasing vs decreasing ECAS scores baseline (at diagnosis), at 1 year
See also
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Not yet recruiting NCT04089696 - Validation of the "ExSpiron©" in Patients With ALS N/A
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Active, not recruiting NCT03067857 - Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease Phase 1/Phase 2
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Active, not recruiting NCT02567136 - Imaging Biomarkers in ALS
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