HealthyGutBrainNCT05934188
Exploring the Gut-Brain Axis in Ageing and Neurodegeneration
An observational study of Healthy and Prodromal Alzheimer's Disease, run by IRCCS San Camillo, Venezia, Italy at 3 sites in Italy.
Trial summary
Neurodegenerative diseases are a major health concern due to their growing societal implications and economic costs. The identification of early markers of pathogenic mechanisms is one of the current main challenges. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Prodromal Alzheimer's Disease, Parkinson Disease
- What is being tested?
- Magnetic Resonance Imaging, Neuropsychological protocol and Eating habits
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 3 sitesItaly
- Study dates
- 1 May 2023to 30 Apr 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The groups will be selected from local community sample, hospital and general practitioners (gp).
Who may be able to join
- Healthy Young and Old Subjects:
- 20-50 or 60-90 years old
- Cognitively healthy (Mini-Mental State examination ≥ 26)
- Absence of significant neurological disorders
- Patients with prodromal Alzheimer's Disease:
- Subjective cognitive complaint (corroborated by the informant)
Show all 20Show fewer
- Episodic memory deficit on neuropsychological testing
- Clinical Dementia Rating = 0.5
- Mini-Mental State Examination (MMSE) > 23
- Independently functioning in activities of daily living
- Patients with Parkinson's Disease:
- Recent diagnosis of Parkinson's Disease
- Mild-moderate score at the Unified Parkinson's Disease Rating Scale (UPDRS)
- Cognitively healthy (Mini-Mental State examination ≥ 26)
- In case of taking medications for Parkinson's Disease: stable dosage for at least 6 months
- Patients with Multiple Sclerosis:
- Recent diagnosis of relapsing-remitting Multiple Sclerosis
- Expanded Disability Status Scale score ≤ 4.0
- Cognitively healthy (Mini-Mental State examination ≥ 26)
- In case of taking medications for Multiple Sclerosis: stable dosage for at least 6 months.
Who cannot join
- For both healthy participants and patients:
- Contraindications to magnetic resonance imaging (metal implant in body, known claustrophobia, pacemakers)
- Severe comorbidities
- Antibiotics treatments over the last 3 months
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, 25125
Moira Marizzoni, mmarizzoni@fatebenefratelli.eu
Moira Marizzoni
- Recruiting
Università Ca' Foscari Venezia
Venice, 30123
Guido Caldarelli, guido.caldarelli@unive.it
Guido Caldarelli
- Recruiting
IRCCS San Camillo
Venice-Lido, Venice, 30126
Nicola Filippini, +39 041 2207304, nicola.filippini@hsancamillo.it
Nicola Filippini
About this study
Official title: Role of the Gut-microbiota on Ageing and Neurodegeneration: a Clinical and Brain Imaging Study
Neurodegenerative diseases are a major health concern due to their growing societal implications and economic costs. The identification of early markers of pathogenic mechanisms is one of the current main challenges. The gut-brain axis has become a primary target because of its transversal role across the neurodegenerative spectrum and its effect on cognition. However, despite recent progress, how changes in the gut-microbiota composition can affect the human brain is still unclear.
The goal of this observational study is to characterise the gut-microbiota composition associated with alterations in brain structure and function during the ageing process and across neurodegenerative disorders. This is based on recent studies showing that changes in the human brain and in the microbiota composition, can indicate very sensitively and in a predictive way pathological development and, consequently, be used as markers of neurodegenerative diseases.
Read more
The main questions it aims to answer are:
- How variation in the gut-microbiota composition correlates with the normal brain ageing trajectory?
- How dysregulation in the gut-microbiota correlates with pathological changes in brain regions in specific neurodegenerative disorders?
- Can the impact of the gut-microbiota on the brain be modulated by blood biomarkers?
The investigators will recruit 40 young healthy participants, 40 old healthy participants, 40 participants with prodromal Alzheimer's Disease, 40 participants with Parkinson's Disease and 40 participants with Multiple Sclerosis.
Participants will undergo the following examinations:
- Magnetic Resonance Imaging
- Analysis of a stool sample
- Analysis of a blood sample
- Neuropsychological assessment
- Questionnaires on eating habits
Read the detailed description
Recent studies show that alterations in the microbiota profile has been observed in the ageing process and across neurodegenerative disorders and it has been associated with cognitive decline and disease-specific clinical symptoms.
The objective of this multicenter observational cross-sectional cohort study is to characterise how changes in the gut-microbiota profile may affect brain changes during the physiological ageing processes and across neurodegenerative disorders with different etiopathogenesis.
The investigators will combine novel magnetic resonance imaging and biological techniques to test these hypotheses:
- Specific functional and structural changes, which reflect unsuccessful compensatory mechanisms to counteract ageing, are associated with changes in the gut-microbiota composition.
- Neurodegenerative disorders (prodromal Alzheimer's Disease, Parkinson's Disease, Multiple Sclerosis) show unique changes in the gut-microbiome profile, associated with specific structural and functional brain changes.
- The microbiota profile characterizing the unsuccessful ageing and different neurodegenerative diseases is associated with alterations in blood biomarkers.
For this study the investigators plan to recruit 80 healthy subjects divided into two groups (40 subjects aged 20-50 years and 40 subjects aged 60-90 years) and 120 patients divided into three groups (40 patients with prodromal Alzheimer's Disease, 40 patients with Parkinson's Disease and 40 patients with Multiple Sclerosis).
All participants will undergo a multimodal Magnetic Resonance Imaging protocol to study the brain structure and function and a detailed neuropsychological protocol to assess cognitive functioning. In addition, stool and blood samples will be collected to investigate the gut-microbiota composition and the presence of inflammatory markers, respectively. Participants will also be asked to fill out questionnaires on eating habits.
There are no known risks or long-term side effects related to Magnetic Resonance Imaging. The performance of the examination does not involve physical or mental impairment.
The study does not directly benefit the participant. However, participation in the study will increase knowledge in the area of the relationship between the gut microbiota and the brain, providing potential new knowledge useful for preventing the risk of developing neurodegenerative processes.
The study takes place at San Camillo IRCCS S.r.l. (70 Alberoni street, Lido VE, 30126, Italy IT).
The study started on 01/05/2023 and the end is planned for 30/04/2026. The submitted study is funded by the Ministry of Health through a finalized research call won by Principal Investigator, Dr. Nicola Filippini, and approved by Ethics Committee for Clinical Trials of the Province of Venice and IRCCS San Camillo, Azienda ULSS 3 Serenissima.
- Being tested
- Magnetic Resonance Imaging, Neuropsychological protocol, Eating habits, Microbiome analyses, Inflammatory markers
- Keywords
- MRI, Microbiota, Stool sample, Blood sample, Neuropsychological assessment, Neuroimaging, Biomarkers for brain disorders
- Medical subject headings
- Parkinson Disease, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
The Magnetic Resonance Imaging protocol will comprise both structural and functional sequences.
Neuropsychological protocolBehavioural
Neuropsychological tests will be administered to participants to assess general cognitive state and a range of high-level cognitive functions (memory, executive, language). In addition, disease-specific tests will be administered to patients to investigate disease staging and the level of disability and autonomy.
Eating habitsBehavioural
Information on eating habits will be derived from food questionnaires.
Microbiome analysesDiagnostic test
The Microbiome analyses will be derived from a stool sample (16S rRNA sequencing targeted metagenomic analyses).
Inflammatory markersDiagnostic test
Inflammatory markers will be evaluated in terms RNA expression level in plasma blood sample.
Alzheimer's Disease biomarkersDiagnostic test
The Alzheimer's Disease biomarkers will be measured in the plasma of prodromal Alzheimer's Disease patients.
| Study group | Role | What they receive |
|---|---|---|
| Young Healthy Subjects (N = 40) | * 20-50 years old
* Cognitively healthy (Mini-Mental State examination ≥ 26)
* Absence of significant neurological disorders Receives: Diagnostic Test: Magnetic Resonance Imaging; Behavioral: Neuropsychological protocol; Behavioral: Eating habits; Diagnostic Test: Microbiome analyses; Diagnostic Test: Inflammatory markers | |
| Old Healthy Subjects (N = 40) | * 60-90 years old
* Cognitively healthy (Mini-Mental State examination ≥ 26)
* Absence of significant neurological disorders Receives: Diagnostic Test: Magnetic Resonance Imaging; Behavioral: Neuropsychological protocol; Behavioral: Eating habits; Diagnostic Test: Microbiome analyses; Diagnostic Test: Inflammatory markers | |
| Patients with prodromal Alzheimer's Disease (N = 40) | * Subjective cognitive complaint (corroborated by the informant)
* Episodic memory deficit on neuropsychological testing
* Clinical Dementia Rating = 0.5
* Mini-Mental State Examination (MMSE) > 23
* Independently functioning in activities of daily living Receives: Diagnostic Test: Magnetic Resonance Imaging; Behavioral: Neuropsychological protocol; Behavioral: Eating habits; Diagnostic Test: Microbiome analyses; Diagnostic Test: Inflammatory markers; Diagnostic Test: Alzheimer's Disease biomarkers | |
| Patients with Parkinson's Disease (N = 40) | * Recent diagnosis of Parkinson's Disease
* Mild-moderate score at the Unified Parkinson's Disease Rating Scale (UPDRS)
* Cognitively healthy (Mini-Mental State examination ≥ 26)
* In case of taking medications for Parkinson's Disease: stable dosage for at least 6 months Receives: Diagnostic Test: Magnetic Resonance Imaging; Behavioral: Neuropsychological protocol; Behavioral: Eating habits; Diagnostic Test: Microbiome analyses; Diagnostic Test: Inflammatory markers | |
| Patients with Multiple Sclerosis (N = 40) | * Recent diagnosis of relapsing-remitting Multiple Sclerosis
* Expanded Disability Status Scale score ≤ 4.0
* Cognitively healthy (Mini-Mental State examination ≥ 26)
* In case of taking medications for Multiple Sclerosis: stable dosage for at least 6 months Receives: Diagnostic Test: Magnetic Resonance Imaging; Behavioral: Neuropsychological protocol; Behavioral: Eating habits; Diagnostic Test: Microbiome analyses; Diagnostic Test: Inflammatory markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain structural and functional properties
Brain structural and functional properties will be derived from a multi-modal Magnetic Resonance Imaging protocol.
Measured: Day 1
Microbiome profile
Microbiome profile will be derived from a stool sample obtained from participants.
Measured: Day 1
Secondary outcomes (3)
Cognitive functioning
Cognitive functions will be measured using a neuropsychological protocol.
Measured: Day 1
Concentration of blood inflammatory markers
A panel of key inflammatory mediators (for example, IFNgamma, IL-6, TNFalpha, IL1beta, IL10) will be evaluated in terms RNA expression level in plasma samples obtained from participants.
Measured: Day 1
Eating habits
Information on eating habits will be derived from food questionnaires.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 May 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Centro San Giovanni di Dio Fatebenefratelli, Università Ca' Foscari Venezia
- Responsible party
- Principal investigator, Nicola Filippini, IRCCS San Camillo, Venezia, Italy
- Investigators
- Nicola Filippini, Principal investigator, IRCCS San Camillo, Venezia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934188
- Sponsor's protocol ID
- 2022.13
- Other IDs
- RF-2021-12372224
- Acronym
- GutBrain
- Status last verified
- Jan 2026
- First submitted
- 9 Jun 2023
- Last updated
- 9 Jan 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Gut-microbiota on Ageing and Neurodegeneration: a Clinical and Brain Imaging Study
- ClinicalTrials.gov ID
- NCT05934188
- Acronym / sponsor ID
- GutBrain / 2022.13
- Keywords
- MRI, Microbiota, Stool sample, Blood sample, Neuropsychological assessment, Neuroimaging, Biomarkers for brain disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Collaborators
- IRCCS Centro San Giovanni di Dio Fatebenefratelli, Università Ca' Foscari Venezia
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 Jul 2023 (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.
Neurodegenerative diseases are a major health concern due to their growing societal implications and economic costs. The identification of early markers of pathogenic mechanisms is one of the current main challenges. The gut-brain axis has become a primary target because of its transversal role across the neurodegenerative spectrum and its effect on cognition. However, despite recent progress, how changes in the gut-microbiota composition can affect the human brain is still unclear.
The goal of this observational study is to characterise the gut-microbiota composition associated with alterations in brain structure and function during the ageing process and across neurodegenerative disorders. This is based on recent studies showing that changes in the human brain and in the microbiota composition, can indicate very sensitively and in a predictive way pathological development and, consequently, be used as markers of neurodegenerative diseases.
The main questions it aims to answer are:
- How variation in the gut-microbiota composition correlates with the normal brain ageing trajectory?
- How dysregulation in the gut-microbiota correlates with pathological changes in brain regions in specific neurodegenerative disorders?
- Can the impact of the gut-microbiota on the brain be modulated by blood biomarkers?
The investigators will recruit 40 young healthy participants, 40 old healthy participants, 40 participants with prodromal Alzheimer's Disease, 40 participants with Parkinson's Disease and 40 participants with Multiple Sclerosis.
Participants will undergo the following examinations:
- Magnetic Resonance Imaging
- Analysis of a stool sample
- Analysis of a blood sample
- Neuropsychological assessment
- Questionnaires on eating habits
Detailed description
Recent studies show that alterations in the microbiota profile has been observed in the ageing process and across neurodegenerative disorders and it has been associated with cognitive decline and disease-specific clinical symptoms.
The objective of this multicenter observational cross-sectional cohort study is to characterise how changes in the gut-microbiota profile may affect brain changes during the physiological ageing processes and across neurodegenerative disorders with different etiopathogenesis.
The investigators will combine novel magnetic resonance imaging and biological techniques to test these hypotheses:
- Specific functional and structural changes, which reflect unsuccessful compensatory mechanisms to counteract ageing, are associated with changes in the gut-microbiota composition.
- Neurodegenerative disorders (prodromal Alzheimer's Disease, Parkinson's Disease, Multiple Sclerosis) show unique changes in the gut-microbiome profile, associated with specific structural and functional brain changes.
- The microbiota profile characterizing the unsuccessful ageing and different neurodegenerative diseases is associated with alterations in blood biomarkers.
For this study the investigators plan to recruit 80 healthy subjects divided into two groups (40 subjects aged 20-50 years and 40 subjects aged 60-90 years) and 120 patients divided into three groups (40 patients with prodromal Alzheimer's Disease, 40 patients with Parkinson's Disease and 40 patients with Multiple Sclerosis).
All participants will undergo a multimodal Magnetic Resonance Imaging protocol to study the brain structure and function and a detailed neuropsychological protocol to assess cognitive functioning. In addition, stool and blood samples will be collected to investigate the gut-microbiota composition and the presence of inflammatory markers, respectively. Participants will also be asked to fill out questionnaires on eating habits.
There are no known risks or long-term side effects related to Magnetic Resonance Imaging. The performance of the examination does not involve physical or mental impairment.
The study does not directly benefit the participant. However, participation in the study will increase knowledge in the area of the relationship between the gut microbiota and the brain, providing potential new knowledge useful for preventing the risk of developing neurodegenerative processes.
The study takes place at San Camillo IRCCS S.r.l. (70 Alberoni street, Lido VE, 30126, Italy IT).
The study started on 01/05/2023 and the end is planned for 30/04/2026. The submitted study is funded by the Ministry of Health through a finalized research call won by Principal Investigator, Dr. Nicola Filippini, and approved by Ethics Committee for Clinical Trials of the Province of Venice and IRCCS San Camillo, Azienda ULSS 3 Serenissima.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Young Healthy Subjects (N = 40) | – | Diagnostic Test: Magnetic Resonance Imaging, Behavioral: Neuropsychological protocol, Behavioral: Eating habits, Diagnostic Test: Microbiome analyses, Diagnostic Test: Inflammatory markers* 20-50 years old * Cognitively healthy (Mini-Mental State examination ≥ 26) * Absence of significant neurological disorders |
| Old Healthy Subjects (N = 40) | – | Diagnostic Test: Magnetic Resonance Imaging, Behavioral: Neuropsychological protocol, Behavioral: Eating habits, Diagnostic Test: Microbiome analyses, Diagnostic Test: Inflammatory markers* 60-90 years old * Cognitively healthy (Mini-Mental State examination ≥ 26) * Absence of significant neurological disorders |
| Patients with prodromal Alzheimer's Disease (N = 40) | – | Diagnostic Test: Magnetic Resonance Imaging, Behavioral: Neuropsychological protocol, Behavioral: Eating habits, Diagnostic Test: Microbiome analyses, Diagnostic Test: Inflammatory markers, Diagnostic Test: Alzheimer's Disease biomarkers* Subjective cognitive complaint (corroborated by the informant) * Episodic memory deficit on neuropsychological testing * Clinical Dementia Rating = 0.5 * Mini-Mental State Examination (MMSE) > 23 * Independently functioning in activities of daily living |
| Patients with Parkinson's Disease (N = 40) | – | Diagnostic Test: Magnetic Resonance Imaging, Behavioral: Neuropsychological protocol, Behavioral: Eating habits, Diagnostic Test: Microbiome analyses, Diagnostic Test: Inflammatory markers* Recent diagnosis of Parkinson's Disease * Mild-moderate score at the Unified Parkinson's Disease Rating Scale (UPDRS) * Cognitively healthy (Mini-Mental State examination ≥ 26) * In case of taking medications for Parkinson's Disease: stable dosage for at least 6 months |
| Patients with Multiple Sclerosis (N = 40) | – | Diagnostic Test: Magnetic Resonance Imaging, Behavioral: Neuropsychological protocol, Behavioral: Eating habits, Diagnostic Test: Microbiome analyses, Diagnostic Test: Inflammatory markers* Recent diagnosis of relapsing-remitting Multiple Sclerosis * Expanded Disability Status Scale score ≤ 4.0 * Cognitively healthy (Mini-Mental State examination ≥ 26) * In case of taking medications for Multiple Sclerosis: stable dosage for at least 6 months |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The groups will be selected from local community sample, hospital and general practitioners (gp).
Key inclusion criteria (20 listed)
- 20-50 or 60-90 years old
- Cognitively healthy (Mini-Mental State examination ≥ 26)
- Absence of significant neurological disorders
- Subjective cognitive complaint (corroborated by the informant)
- Episodic memory deficit on neuropsychological testing
Key exclusion criteria (4 listed)
- Contraindications to magnetic resonance imaging (metal implant in body, known claustrophobia, pacemakers)
- Severe comorbidities
- Antibiotics treatments over the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingThe Magnetic Resonance Imaging protocol will comprise both structural and functional sequences. | Diagnostic test | Old Healthy Subjects (N = 40), Patients with Multiple Sclerosis (N = 40), Patients with Parkinson's Disease (N = 40), Patients with prodromal Alzheimer's Disease (N = 40), Young Healthy Subjects (N = 40) |
| Neuropsychological protocolNeuropsychological tests will be administered to participants to assess general cognitive state and a range of high-level cognitive functions (memory, executive, language). In addition, disease-specific tests will be administered to patients to investigate disease staging and the level of disability and autonomy. | Behavioural | Old Healthy Subjects (N = 40), Patients with Multiple Sclerosis (N = 40), Patients with Parkinson's Disease (N = 40), Patients with prodromal Alzheimer's Disease (N = 40), Young Healthy Subjects (N = 40) |
| Eating habitsInformation on eating habits will be derived from food questionnaires. | Behavioural | Old Healthy Subjects (N = 40), Patients with Multiple Sclerosis (N = 40), Patients with Parkinson's Disease (N = 40), Patients with prodromal Alzheimer's Disease (N = 40), Young Healthy Subjects (N = 40) |
| Microbiome analysesThe Microbiome analyses will be derived from a stool sample (16S rRNA sequencing targeted metagenomic analyses). | Diagnostic test | Old Healthy Subjects (N = 40), Patients with Multiple Sclerosis (N = 40), Patients with Parkinson's Disease (N = 40), Patients with prodromal Alzheimer's Disease (N = 40), Young Healthy Subjects (N = 40) |
| Inflammatory markersInflammatory markers will be evaluated in terms RNA expression level in plasma blood sample. | Diagnostic test | Old Healthy Subjects (N = 40), Patients with Multiple Sclerosis (N = 40), Patients with Parkinson's Disease (N = 40), Patients with prodromal Alzheimer's Disease (N = 40), Young Healthy Subjects (N = 40) |
| Alzheimer's Disease biomarkersThe Alzheimer's Disease biomarkers will be measured in the plasma of prodromal Alzheimer's Disease patients. | Diagnostic test | Patients with prodromal Alzheimer's Disease (N = 40) |
Primary outcome
Brain structural and functional properties
Time frame: Day 1
Brain structural and functional properties will be derived from a multi-modal Magnetic Resonance Imaging protocol.
Microbiome profile
Time frame: Day 1
Microbiome profile will be derived from a stool sample obtained from participants.
3 secondary outcomes
Cognitive functioning
Time frame: Day 1
Concentration of blood inflammatory markers
Time frame: Day 1
Eating habits
Time frame: Day 1
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 9 Jan 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.
Nicola Filippini principal investigator
IRCCS San Camillo, Venezia, Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Prodromal Alzheimer's Disease, run by IRCCS San Camillo, Venezia, Italy at 3 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 20 inclusion and 4 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 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Nicola Filippini (+39 041 2207304, nicola.filippini@hsancamillo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain structural and functional properties (time frame: Day 1). The study lists 2 primary outcomes in all. 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 9 Jan 2026.