Neurological DisordersM-BrainNCT07477821
A Muscle-brain Interplay Study in Neurological Disorders
An observational study of Neurological Disorders and Health Adult Subjects, run by Istituti Clinici Scientifici Maugeri SpA at 4 sites in Italy.
Trial summary
Despite the improvements in life expectancy, neurodegenerative diseases (NDGs) have become the most dreaded disorders of older people. Aged brains show characteristic changes that are linked to neurodegeneration raising the question of whether these hallmarks represent the harbingers of NDGs. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurological Disorders, Health Adult Subjects
- How many people
- 150 participants
- Where
- 4 sitesItaly
- Study dates
- 24 Jul 2025to 28 Feb 2027
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients to be enrolled in the study will be those admitted at the hospitals involved in the project. Healthy volunteers may be recruited among patients' relatives or among hospital staff who are not involved in the study.
Who may be able to join
- for Good aging group:
- Subjects aged 60 years or older
- Frailty Index below the pathological cut-off (>0.25)
- Absence of general cognitive impairment (MMSE > 24 points)
- Absence of a diagnosis of sarcopenia
- for Bad aging group:
Show all 14Show fewer
- Patients aged over 60 years
- Exclusive presence of one of the following diagnoses:
- Definite, probable, or probable laboratory-supported Amyotrophic Lateral Sclerosis (ALS), either sporadic or familial, according to the revised El Escorial Criteria for ALS diagnosis.
- Parkinson's disease (PD) according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., Mov Disord., 2015 Oct; 30(12): 1591-1601).
- Alzheimer's disease (AD), possible or probable, according to international diagnostic guidelines.
- Diagnosis of severe acquired brain injury according to the Italian Guidelines for the Care of Patients in Vegetative State and Minimally Conscious State 2011 (approved by the Unified Conference on May 5, 2011 - Ministry of Health, Italy), with the presence of Sarcopenia.
- Presence of Mild Cognitive Impairment (MCI), subjective memory complaint, or deficit in a single cognitive domain, according to international criteria and in absence of established neurological diseases and sarcopenia.
- Presence of Sarcopenia as defined by the EWGSOP2 Sarcopenia Consensus, in the absence of cognitive deficits and established neurological diseases.
Who cannot join
- Inability to provide informed consent.
- Presence of severe and/or acute comorbidities (e.g., uncontrolled diabetes, heart failure, or a diagnosis of oncological disease), as determined by the research team.
- Evidence of other previous neurological or psychiatric disorders involving the cognitive domain.
- Uncontrolled or complicated systemic diseases or history of traumatic brain injury.
- For subjects with Alzheimer's disease (AD), Parkinson's disease (PD), and Amyotrophic Lateral Sclerosis (ALS), individuals with a history of epilepsy will also be excluded.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 2 recruiting
- Active, not recruiting
Universita degli Studi di Catania
Catania, 95131
- Recruiting
IRCCS Centro Neurolesi Bonino Pulejo
Messina, 98123
Maria Cristina De Cola, MS, +3909060128417, mariacristina.decola@irccsme.it
Maria Cristina De Cola, MS
- Recruiting
Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute
Milan, 20138
Riccardo Sideri, MS, +390250725261, riccardo.sideri@icsmaugeri.it
Christian Lunetta, MD
- Active, not recruiting
University of Roma La Sapienza
Roma, 00185
About this study
Official title: A Translational Approach to Characterize the Muscle-brain Interplay in Neurological Non-communicable Diseases. The M-Brain Project
Despite the improvements in life expectancy, neurodegenerative diseases (NDGs) have become the most dreaded disorders of older people. Aged brains show characteristic changes that are linked to neurodegeneration raising the question of whether these hallmarks represent the harbingers of NDGs. Lifestyle factors including, in particular physical exercise, have given particular attention to factors associated to movement issue as ones of the major factors in modulating the risk of developing NDGs, emphasizing the interest in the muscle-brain axis. Indeed, one of the crucial systems severely affected in several neuromuscular diseases is the loss of effective connection between muscle and nerve, and the neuromuscular junction (NMJ) represents the critical region at the level of which the two entities communicate.
Even if controversy exists on whether pathological events beginning at the NMJ precede or follow loss of motor units, some recent data highlight as NGDs (e.g. Amyotrophic Lateral Sclerosis, Alzheimer's Disease, and Parkinson's Disease) and Aging share some common pathologic features such as the loss of fast-twich fiber, a decreased number of synaptic vesicles and sarcopenia giving evidence supports the notion that NMJ dismantlement can occur independently from motor neuron degeneration and may represent an early pathogenic signature of muscle-nerve communication defects.
Read more
The M-Brain project is an observational, analytical case-control study that will apply a new approach to interpret data underling the NMJ dismantlement in NDGs patients by comparing their clinical and biological information with data obtained from people who have had a so called "good aging" and those who have had a "bad aging".
The study will collect data useful to identify potential predisposing or risk factors for the subsequent development of a NDGs or able to predict the phenotype traiectories of selected pathologies with differerent movement levels. The combination of a muscular and neurological phenotyping and a biological characterization combining biomarkers, miRNA and extracellular vesicle (EV) assessments will allow to better identify the determinants of muscle-brain cross-talk that can then be used as potential indicators for the definition of critical morphological and functional components involved in aging and some NGDs. The project then will aim to identify phenotyope trajectories of patients giving particular attention to the brain-muscle axis and movement issues in order to provide information useful for future clinical strategies able to minimaze risk/predisponent Factors.
- Conditions
- Neurological Disorders, Health Adult Subjects
- Keywords
- muscle, brain, aging, Neuromuscolar
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bad Aging Group | This group include: 1. No-neurodegenerative disease group (No-NDG) that will comprehend: (i) subjects with an age older than 60 years and with or without sarcopenia and/or neurological impairment (such as mild cognitive impairments or extrapyramidal signs) and (ii) Patients (pts) with Severe Acquired Brain Injury (sABI) that are characterised by sarcopenia and cognitive impairment 2. The Neurodegenerative disease group (NDG) that will comprehend: ALS with or without cognitive impairments/sarcopenia; Alzheimer Disease (AD) with or without sarcopenia and Parkinson Disease (PD) with or without sarcopenia | |
| Good Aging Group | This group will include subjects aged more than 60 years and without muscular (e.g. sarcopenia) and/or neurological (e.g. cognitive) impairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in The Edmonton Frail Scale (EFS)
The EFS is one of just a few frailty assessment tools that capture multidimensional aspects of frailty. The EFS is used to flag more specific issues that warrant closer attention and follow up. In this way, healthcare providers can use frailty information to create an individualized care plan to be discussed with the person who has been assessed.
Measured: At baseline and T1 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start24 Jul 2025
- Primary completionOct 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisordersStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza, University of Catania, IRCCS Centro Neurolesi Bonino Pulejo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477821
- Sponsor's protocol ID
- PNRR-MCNT1-2023 12378447
- Acronym
- M-Brain
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Translational Approach to Characterize the Muscle-brain Interplay in Neurological Non-communicable Diseases. The M-Brain Project
- ClinicalTrials.gov ID
- NCT07477821
- Acronym / sponsor ID
- M-Brain / PNRR-MCNT1-2023 12378447
- Conditions
- Neurological Disorders, Health Adult Subjects
- Keywords
- muscle, brain, aging, Neuromuscolar
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza, University of Catania, IRCCS Centro Neurolesi Bonino Pulejo
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 17 Mar 2026 (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.
Despite the improvements in life expectancy, neurodegenerative diseases (NDGs) have become the most dreaded disorders of older people. Aged brains show characteristic changes that are linked to neurodegeneration raising the question of whether these hallmarks represent the harbingers of NDGs. Lifestyle factors including, in particular physical exercise, have given particular attention to factors associated to movement issue as ones of the major factors in modulating the risk of developing NDGs, emphasizing the interest in the muscle-brain axis. Indeed, one of the crucial systems severely affected in several neuromuscular diseases is the loss of effective connection between muscle and nerve, and the neuromuscular junction (NMJ) represents the critical region at the level of which the two entities communicate.
Even if controversy exists on whether pathological events beginning at the NMJ precede or follow loss of motor units, some recent data highlight as NGDs (e.g. Amyotrophic Lateral Sclerosis, Alzheimer's Disease, and Parkinson's Disease) and Aging share some common pathologic features such as the loss of fast-twich fiber, a decreased number of synaptic vesicles and sarcopenia giving evidence supports the notion that NMJ dismantlement can occur independently from motor neuron degeneration and may represent an early pathogenic signature of muscle-nerve communication defects.
The M-Brain project is an observational, analytical case-control study that will apply a new approach to interpret data underling the NMJ dismantlement in NDGs patients by comparing their clinical and biological information with data obtained from people who have had a so called "good aging" and those who have had a "bad aging".
The study will collect data useful to identify potential predisposing or risk factors for the subsequent development of a NDGs or able to predict the phenotype traiectories of selected pathologies with differerent movement levels. The combination of a muscular and neurological phenotyping and a biological characterization combining biomarkers, miRNA and extracellular vesicle (EV) assessments will allow to better identify the determinants of muscle-brain cross-talk that can then be used as potential indicators for the definition of critical morphological and functional components involved in aging and some NGDs. The project then will aim to identify phenotyope trajectories of patients giving particular attention to the brain-muscle axis and movement issues in order to provide information useful for future clinical strategies able to minimaze risk/predisponent Factors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bad Aging Group | – | –This group include: 1. No-neurodegenerative disease group (No-NDG) that will comprehend: (i) subjects with an age older than 60 years and with or without sarcopenia and/or neurological impairment (such as mild cognitive impairments or extrapyramidal signs) and (ii) Patients (pts) with Severe Acquired Brain Injury (sABI) that are characterised by sarcopenia and cognitive impairment 2. The Neurodegenerative disease group (NDG) that will comprehend: ALS with or without cognitive impairments/sarcopenia; Alzheimer Disease (AD) with or without sarcopenia and Parkinson Disease (PD) with or without sarcopenia |
| Good Aging Group | – | –This group will include subjects aged more than 60 years and without muscular (e.g. sarcopenia) and/or neurological (e.g. cognitive) impairment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients to be enrolled in the study will be those admitted at the hospitals involved in the project. Healthy volunteers may be recruited among patients' relatives or among hospital staff who are not involved in the study.
Key inclusion criteria (14 listed)
- Subjects aged 60 years or older
- Frailty Index below the pathological cut-off (>0.25)
- Absence of general cognitive impairment (MMSE > 24 points)
- Absence of a diagnosis of sarcopenia
- Patients aged over 60 years
Key exclusion criteria (5 listed)
- Inability to provide informed consent.
- Presence of severe and/or acute comorbidities (e.g., uncontrolled diabetes, heart failure, or a diagnosis of oncological disease), as determined by the research team.
- Evidence of other previous neurological or psychiatric disorders involving the cognitive domain.
- Uncontrolled or complicated systemic diseases or history of traumatic brain injury.
- For subjects with Alzheimer's disease (AD), Parkinson's disease (PD), and Amyotrophic Lateral Sclerosis (ALS), individuals with a history of epilepsy will also be excluded.
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
Change from baseline in The Edmonton Frail Scale (EFS)
Time frame: At baseline and T1 (6 months)
The EFS is one of just a few frailty assessment tools that capture multidimensional aspects of frailty. The EFS is used to flag more specific issues that warrant closer attention and follow up. In this way, healthcare providers can use frailty information to create an individualized care plan to be discussed with the person who has been assessed.
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 17 Mar 2026.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Disorders and Health Adult Subjects, run by Istituti Clinici Scientifici Maugeri SpA at 4 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 14 inclusion and 5 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Christian Lunetta, MD (+39 0250725266, christian.lunetta@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in The Edmonton Frail Scale (EFS) (time frame: At baseline and T1 (6 months)). 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 17 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.