Amyotrophic Lateral SclerosisDRIVEALSNCT06318598
Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Istituto Auxologico Italiano at 3 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
- How many people
- 200 participants
- Where
- 3 sitesItaly
- Study dates
- 11 Apr 2023to 10 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive cohort of incident patients from three Italian ALS Centers
Who may be able to join
- diagnosis of ALS or other motor neuron disease
- residence near the study centers
Who cannot join
- refusal to participate to the study
- unable/unwilling to perform follow-up visits
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
Ospedale San Raffaele
Milan, MI, 20132
Yuri Falzone, MD, PhD
- Recruiting
Ospedale San Luca
Milan, MI, 20149
Alberto Doretti, MD, +0261911 ext. 2937, a.doretti@auxologico.it
- Recruiting
AOU Città della Salute e della Scienza
Torino, TO, 10126
Adriano Chiò, MD
About this study
Official title: Dissezione Fenotipica Guidata da Biomarcatori Della Sclerosi Laterale Amiotrofica/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
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic screening
no. of patients with ALS-associated mutations
Measured: baseline (at diagnosis)
biomarker assessment
no. of patients with abnormal NfL, GFAP, tau, UCHL1, MCP1 and TDP-43 levels
Measured: baseline (at diagnosis), at 6 months, at 1 year
Secondary outcomes (2)
clinical assessment
no. of patients with increasing vs decreasing PUMNS/LMNS scores
Measured: baseline (at diagnosis), at 6 months, at 1 year
neuropsychological assessment
no. of patients with increasing vs decreasing ECAS scores
Measured: baseline (at diagnosis), at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start11 Apr 2023
- Primary completion10 Apr 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza, Ospedale San Raffaele
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318598
- Sponsor's protocol ID
- 23M202
- Acronym
- DRIVEALS
- Status last verified
- May 2025
- First submitted
- 8 Mar 2024
- Last updated
- 7 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissezione Fenotipica Guidata da Biomarcatori Della Sclerosi Laterale Amiotrofica/Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT06318598
- Acronym / sponsor ID
- DRIVEALS / 23M202
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza, Ospedale San Raffaele
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive cohort of incident patients from three Italian ALS Centers
Key inclusion criteria (2 listed)
- diagnosis of ALS or other motor neuron disease
- residence near the study centers
Key exclusion criteria (2 listed)
- refusal to participate to the study
- unable/unwilling to perform follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
genetic screening
Time frame: baseline (at diagnosis)
no. of patients with ALS-associated mutations
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
2 secondary outcomes
clinical assessment
Time frame: baseline (at diagnosis), at 6 months, at 1 year
neuropsychological assessment
Time frame: baseline (at diagnosis), at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Istituto Auxologico Italiano at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola Ticozzi, MD, PhD (+390261911 ext. 2937, n.ticozzi@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genetic screening (time frame: baseline (at diagnosis)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.