NCT07302321Recruiting
Needs of ALS Patients With C9orf72 Mutation and Their Caregivers
Investigation Into the Needs of ALS Patients With C9orf72 Mutation and Their Caregivers
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
Individuals with Amyotrophic Lateral Sclerosis (ALS) carrying the C9orf72 HRE mutation (C9Pos) often exhibit different phenotypic traits compared to other patients (C9Neg), presenting a more aggressive form of the disease, with also a higher frequency of comorbidity with frontotemporal dementia (ALS-FTD) and a greater prevalence of family history of ALS and/or other neurodegenerative diseases. Considering these characteristics (comorbidity with FTD and family history of ALS and/or other neurodegenerative pathologies) as factors that have their importance from an assistance point of view, both C9orf72 patients and their caregivers may have particular needs in several respects, and in this sense this investigation is configured. This survey aims to describe the various aspects related to the care and quality of life of C9orf72 ALS patients and their respective caregivers, with the goal of identifying actionable steps to improve the quality of life for both.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 208 (estimated)
- First submitted
- 28 Nov 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Istituto Auxologico Italiano
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07302321
What you commit to
- Study type: Observational
- Planned participants: 208
- From 1 Oct 2025 to the primary completion date, 31 Mar 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Clinically relevant cognitive dysfunction
- Incapacity to reply to at least half of the questions of the online survey
- Hospital Anxiety and Depression Scale (HADS) ≥ 11
- Caregivers:
Who the study is looking for
- Diagnosis of ALS with mutation C9orf72 (C9Pos)
- Age 18 years or older
- Fluency in Italian language
- Ability to understand the nature of the study and to reply to the questions in the online survey
- Informed consent signed
- Caregiver of patient with diagnosis of ALS with mutation C9orf72 (C9Pos), who participates in this study
- Age 18 years or older
- Preserved cognitive functions
- Informed consent signed
Criteria the registry did not label
- ALS Patients:
Age in the registry: 18 years to - · Sex: All
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Auxologico Italiano IRCCS Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| IRCCS Fondazione Mondino, Istituto Neurologico Nazionale a Carattere Scientifico Coordinator of this site? Confirm its status | Pavia | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.