NCT07302321 Needs of ALS Patients With C9orf72 Mutation and Their Caregivers
| NCT ID | NCT07302321 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Auxologico Italiano |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 208 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 208 participants in total. It began in 2025-10-01 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
ALS Patients: Inclusion Criteria: * 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 Exclusion Criteria: * 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: Inclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07302321 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07302321 currently recruiting?
Yes, NCT07302321 is actively recruiting participants. Contact the research team at vincenzo.silani@unimi.it for enrollment information.
Where is the NCT07302321 trial being conducted?
This trial is being conducted at Milan, Italy, Milan, Italy, Pavia, Italy.
Who is sponsoring the NCT07302321 clinical trial?
NCT07302321 is sponsored by Istituto Auxologico Italiano. The trial plans to enroll 208 participants.
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