Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT07268833
Eligibility Criteria:
Inclusion Criteria for als patients:
* Age equal or over 18 years old
* ALS patients, diagnosed accordingly to the revised El Escorial Criteria
* Disease duration \<24 months from symptom onset.
Exclusion Criteria for als patients:
* FVC \<60%;
* nutritional or respiratory failure;
* significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.
Inclusion criteria for ALS pre-symptomatic patients
* Age equal or over 18 years old
* Patients with genetic defined susceptibility to ALS and one or more strict relative affected from ALS Exclusion criteria for ALS pre-symptomatic patients
* significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.
Inclusion criteria for controls
* Age equal or over 18 years old
* Subjects without a diagnosis of neurodegenerative disease or neuromuscular disorder.
Exclusion criteria for controls
• significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.
Inclusion criteria for non ALS neurodegenerative patients
* Age equal or over 18 years old
* For AD: Diagnosis according to 2018 NIA-AA Framework for Alzheimer's Disease
* For FTD: Diagnosis according to 2011 International Behavioural Variant FTD Criteria Consortium
* For PD: Diagnosis according to 2015 Movement Disorder Society criteria
* For DLB: Diagnosis according to 2017 Fourth Consensus Report of the DLB Consortium Exclusion criteria for non ALS neurodegenerative patients
* significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.
Inclusion criteria for neuromuscular disease patients
* Age equal or over 18 years old
* Presence of axonal or demyelinating neuropathy Exclusion criteria for neuromuscular patients
* significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07268833
Study Brief:
Protocol Section:
NCT07268833