NCT06318598

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

March 8, 2024

Last Update Submit

May 5, 2025

Conditions

Amyotrophic Lateral SclerosisMotor Neuron Disease

Outcome Measures

Primary Outcomes (2)

  • genetic screening

    no. of patients with ALS-associated mutations

    baseline (at diagnosis)

  • 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 Outcomes (2)

  • clinical assessment

    baseline (at diagnosis), at 6 months, at 1 year

  • neuropsychological assessment

    baseline (at diagnosis), at 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive cohort of incident patients from three Italian ALS Centers

You may qualify if:

  • diagnosis of ALS or other motor neuron disease
  • residence near the study centers

You may not qualify if:

  • refusal to participate to the study
  • unable/unwilling to perform follow-up visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

Ospedale San Luca

Milan, MI, 20149, Italy

RECRUITING

AOU Città della Salute e della Scienza

Torino, TO, 10126, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA, plasma, serum, CSF

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisMotor Neuron Disease

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Nicola Ticozzi, MD, PhD

CONTACT

+390261911n.ticozzi@auxologico.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 19, 2024

Study Start

April 11, 2023

Primary Completion

April 10, 2026

Study Completion

April 10, 2026

Last Updated

May 7, 2025

Record last verified: 2025-05

Locations

IT(3)