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Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis (DRIVEALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06318598
Recruitment Status : Recruiting
First Posted : March 19, 2024
Last Update Posted : March 19, 2024
Sponsor:
Collaborators:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Ospedale San Raffaele
Information provided by (Responsible Party):
Istituto Auxologico Italiano

Study Description
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Brief 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

Condition or disease
Amyotrophic Lateral Sclerosis Motor Neuron Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dissezione Fenotipica Guidata da Biomarcatori Della Sclerosi Laterale Amiotrofica/Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis
Actual Study Start Date : April 11, 2023
Estimated Primary Completion Date : April 10, 2026
Estimated Study Completion Date : April 10, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. genetic screening [ Time Frame: baseline (at diagnosis) ]
    no. of patients with ALS-associated mutations

  2. biomarker assessment [ Time Frame: baseline (at diagnosis), at 6 months, at 1 year ]
    no. of patients with abnormal NfL, GFAP, tau, UCHL1, MCP1 and TDP-43 levels


Secondary Outcome Measures :
  1. clinical assessment [ Time Frame: baseline (at diagnosis), at 6 months, at 1 year ]
    no. of patients with increasing vs decreasing PUMNS/LMNS scores

  2. neuropsychological assessment [ Time Frame: baseline (at diagnosis), at 1 year ]
    no. of patients with increasing vs decreasing ECAS scores


Biospecimen Retention:   Samples With DNA
DNA, plasma, serum, CSF

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive cohort of incident patients from three Italian ALS Centers
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06318598


Contacts
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Contact: Nicola Ticozzi, MD, PhD +390261911 ext 2937 n.ticozzi@auxologico.it

Locations
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Italy
Ospedale San Raffaele Recruiting
Milano, MI, Italy, 20132
Contact: Yuri Falzone, MD, PhD         
Ospedale San Luca Recruiting
Milano, MI, Italy, 20149
Contact: Alberto Doretti, MD    +0261911 ext 2937    a.doretti@auxologico.it   
AOU Città della Salute e della Scienza Recruiting
Torino, TO, Italy, 10126
Contact: Adriano Chiò, MD         
Sponsors and Collaborators
Istituto Auxologico Italiano
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Ospedale San Raffaele
More Information
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Responsible Party: Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT06318598    
Other Study ID Numbers: 23M202
First Posted: March 19, 2024    Key Record Dates
Last Update Posted: March 19, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases