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NCT Number: NCT06318598

Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis

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

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale San Luca, Milan, MI, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Nicola Ticozzi, MD, PhD

CONTACT

[email protected]

+390261911 ext. 2937

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Collaborators

  • A.O.U. Città della Salute e della Scienza
  • Ospedale San Raffaele

Registry information

Official study title

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

Acronym: DRIVEALS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2024
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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