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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

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