No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
400 (estimated)
Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Other
Who this trial is looking for
This trial is looking for adults with Amyotrophic Lateral Sclerosis (ALS), including some at risk for developing the condition. Participants will help researchers understand ALS better and develop new ways to detect and treat it.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older
I have been diagnosed with ALS
My ALS symptoms started less than 24 months ago
I have a family member with ALS if I am at risk for it
You may not be able to join if
My forced vital capacity (FVC) is less than 60%
I have nutritional failure
I have respiratory failure
I have significant liver failure
I have chronic kidney failure
I have any major infections or metabolic issues that affect my health
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The progress of ALS research and clinical practice is hampered by lack of effective biomarkers to monitor disease onset and progression. In response to this urgent need, we will integrate single-cell system biology approaches, histopathological and clinical data from precious human nerve biopsies collected from living ALS patients during the diagnostic workup and findings from innovative preclinic…
The progress of ALS research and clinical practice is hampered by lack of effective biomarkers to monitor disease onset and progression. In response to this urgent need, we will integrate single-cell system biology approaches, histopathological and clinical data from precious human nerve biopsies collected from living ALS patients during the diagnostic workup and findings from innovative preclinical mouse models to unmask cell-specific molecular alterations that arise in the PNS tissue during the course of ALS pathology. This information will be used to select protein biomarkers of dysfunctional states associated with pre-manifest or early symptomatic stages of the disease, which will be further screened and validated in patient biofluids. Altogether, this project will lead to the discovery of novel, reliable and specific ALS biomarkers while providing insights into ALS mechanisms by leveraging an original "PNS perspective" on disease pathogenesis.
Trial Locations
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Status
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 …
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.
Contacts
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