Neurodegenerative DisordersSANDYNCT06875739
An Innovative Method in SAliva Samples for the Early Differential Diagnosis of High-impact NeuroDegenerative Diseases Through Raman Spectroscopy
An observational study of Neurodegenerative Disorders and Parkinson Disease, run by Fondazione Don Carlo Gnocchi ETS at 4 sites in Italy.
Trial summary
The aim of the study is to validate a salivary test that allows for rapid and accurate objective diagnosis in the context of neurodegenerative diseases, a complex of diseases that includes Alzheimer's Dementia, Frontotemporal Dementia, Parkinson's Disease, Atypical Parkinsonisms, and Amyotrophic Lateral Sclerosis. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Neurodegenerative Disorders, Parkinson Disease, Alzheimer Disease
- How many people
- 310 participants
- Where
- 4 sitesItaly
- Study dates
- 14 Feb 2025to 1 Oct 2026
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NDDs will be recruited from participating centers through enrollment. We plan to recruit at least 52 subjects per experimental group (52 ADDs, 52 FTDs, 52 PDs, 52 APs, 52 ALS) and 50 CTRLs. An additional 50 prodromal cases belonging to the PD, FTD behavioral variant, and AD categories.
Who may be able to join
- FOR ALL SUBJECTS: between 60 and 85 years old
- FOR CASE:
- ADD: diagnosis of dementia due to AD according to clinical criteria and supported by amyloid biomarkers (biomarkers in CSF or brain PET scan with amyloid-specific tracer) according to the definition biological or neurochemical definition of disease.
- FTD: diagnosis of FTD-bv (behavioral variant) according to current clinical criteria.
- PD: diagnosis according to MDS criteria; stable drug treatment (last 4 weeks).
- APs: clinical diagnosis of Progressive Supranuclear Palsy according to the criteria of Hoglinger 2017, Corticobasal Degeneration according to the criteria of Armostrong 2013, Multisystem Atrophy according to the criteria of Wenning 2022.
Show all 18Show fewer
- ALS: clinical diagnosis according to the criteria of Brooks (2000) and subsequent revisions.
- FOR CONTROL SUBJECTS
- subjects admitted to IRCCS Don Gnocchi Florence in the departments of cardiology, pulmonology, orthopedics
- ABSENCE of neurological symptoms
- ABSENCE OF diagnosis of neurological or psychiatric diseases.
- absence of positive family history (relatives I and II degree) for NDDs.
- condition of clinical stability
- at least 15 days after the acute event causing hospitalization.
- FOR PRODROMAL CASE
- Prodromal PD according to Berg's criteria.
- prodromal FTD-bv according to Barker's criteria
- prodromal AD according to the criteria of Dubois and Albert
Who cannot join
- FOR CASE
- Vascular Parkinsonism and other forms of secondary Parkinsonism such as drug-induced, other known or suspected causes (metabolic, brain tumor, etc.).
- MoCA<15 for subjects with PD
- cases with validated biomarkers (CSF and PET) in diagnostic conflict.
- FOR ALL SUBJECTS
- significant comorbidities
Show all 11Show fewer
- presence of severe systemic diseases or previously diagnosed psychiatric illnesses
- patients unable to express consent for participation in the study themselves
- presence of clinically unstable oral cavity disease (inflammatory/infectious)
- time since acute event (if it occurred) <15 days
- presence of local or systemic infection/inflammation detected on routine examinations.
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
Azienda Ospedaliera Universitaria di Cagliari
Cagliari
IRCCS Fondazione Don Carlo Gnocchi
Florence
Laboratorio Congiunto di Ricerca DON GNOCCHI - UNIFI neurogenetica in riabilitazione - NGR
Florence
IRCCS Fondazione Don Carlo Gnocchi, Milano
Milan
About this study
The aim of the study is to validate a salivary test that allows for rapid and accurate objective diagnosis in the context of neurodegenerative diseases, a complex of diseases that includes Alzheimer's Dementia, Frontotemporal Dementia, Parkinson's Disease, Atypical Parkinsonisms, and Amyotrophic Lateral Sclerosis. In particular, the study aims to validate the salivary method against methods already in use (CSF method) or better studied (blood-based method) to allow early recognition of the disease condition and a distinction between the various diseases in order to receive appropriate therapy when possible.
In fact, the term neurodegenerative diseases is a broad term that includes disorders characterized by predominantly cognitive, motor, or mixed disorders for which early and accurate diagnosis of the disease is often difficult given also the variability with which these diseases can present. Ab initio recognition of a specific neurodegenerative disease would allow better pharmacological management of this disorder and facilitate the planning of care and rehabilitation interventions. In general, the recognition of neurodegenerative diseases could be facilitated by the use of a biomarker, which is a biological indicator that can be related to the onset or development of a disease. For this reason, it is necessary to compare the biomarker assay of patients with that of controls, so you were asked to participate as a "Control Subject" precisely because you do not have neurodegenerative disease.
Read more
Participation in the study involves, in addition to the collection of clinical-demographic data, the performance of a cognitive screening test to attest that your cognitive performance is in the normal range and the collection of biological blood and salivary samples, to be compared with those of participants with neurodegenerative diseases. Apolipoprotein E (ApoE) polymorphism study will be performed on the blood. A genetic polymorphism is a variation in the DNA sequence present in at least 1% of the population, the determination of ApoE polymorphism will allow to define a His genetic characteristic related to a higher or lower risk of developing Alzheimer's Disease. Two specific biomarkers, called neurofilament light chain (NfL) and gliofibrillary acidic protein (GFAP), namely a marker of neurodegeneration and one of neuroinflammation, will also be assayed on blood. Analysis of some inflammatory proteins called cytokines will also be performed.
On saliva, the biochemical composition will be evaluated with the analysis of particles present within it called vesicles by a method called Raman Spectroscopy, and the assay of specific biomarkers called NfL and GFAP will also be performed on saliva. The diagnosis of pathology made according to clinical diagnostic criteria and supported, when necessary, by the presence of recognized biomarkers (molecular imaging/liquid markers) will be used as a reference to evaluate the diagnostic capabilities of salivary methodology to detect different pathologies and to differentiate a pathological condition from Controls. Finally, the study will also include a comparison of salivary study methods on a group of people who are at a very early stage of disease, in order to detect whether the study performed with portable instrumentation is as good a method as that with laboratory instrumentation. In fact, the use of portable instrumentation would make it even easier to acquire a biomarker quickly directly from the clinic.
- Conditions
- Neurodegenerative Disorders, Parkinson Disease, Alzheimer Disease, Parkinsonian Disorders, Fronto-temporal Dementia, Amyotrophic Lateral Sclerosis
- Medical subject headings
- Neurodegenerative Diseases, Parkinson Disease, Alzheimer Disease, Parkinsonian Disorders, Amyotrophic Lateral Sclerosis
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 |
|---|---|---|
| control subjects | They are subjects admitted to IRCCS Don Gnocchi Florence in the cardiology, pulmonology, and orthopedics departments who have no neurological symptoms or diagnosis of neurological or psychiatric diseases, in the absence of positive family history (relatives I and II degree) for NDDs. Control subjects should be in a clinically stable condition at inclusion, and will be enrolled at least 15 days after the acute event causing hospitalization. | |
| cases | They are individuals with a diagnosis of alzheimer's dementia, diagnosis of fronto-temporal dementia(behavioral variant), diagnosis of Parkinson's disease, clinical diagnosis of Parkinsonisms, and clinical diagnosis of amyotrophic lateral sclerosis. | |
| prodromal cases | Subjects with Parkinson's or Alzheimer's disease or Frontotemporal dementia (behavioral variant) in the prodromal stage according to Berg's criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Illness Rating Scale (CIRS)
it's a scale that records the comorbidity
Measured: at enrollment
Neurological Clinical informations
Presence/absence of symptoms/signs such as presence of speech disorder, hearing loss, low vision, dysphagia, oculomotricity disorder, disorientation, decreased insight, fatuity, perseveration/affacceleration, dx/sn recognition inability, gait disorder, instability/falls, neglect, ideomotor apraxia, signs of frontal release, rigidity/spasticity, bradykinesia, tremor or other involuntary movements, signs of first or second motor neuron, need for use of aids/presence of medical aids.
Measured: at enrollment
Genetic test
genetic testing will lead in NDDs and CTRL to the determination of the ApoE polymorphism (categorical variable). In NDDs, diagnostic investigation will aim to confirm/exclude a mutation in one of the disease-causing genes (APP, PS1, PS2, MAPT, PGRN, C9ORF72, SOD 1, TARDBP, VCP) in accordance with the pathological phenotype
Measured: at enrollment
Plasma test
NfL and GFAP assay result on plasma (continuous numeric variables)
Measured: at enrollment
Salivary test
results of NfL and GFAP assay on saliva (continuous numeric variables)
Measured: at enrollment
nerological objective examination checklist
presence/absence of symptoms/signs such as presence of speech disorder, hearing impairment, low vision, dysphagia, oculomotor disorder, disorientation, decreased insight, fatuity, perseveration/affacility, dx/sn recognition inability, gait disorder, instability/falls, neglect, ideomotor apraxia, signs of frontal release, rigidity/spasticity, bradykinesia, tremor or other involuntary movements, signs of first or second motor neuron,need for use of aids/presence of medical aids (categorical variables)
Measured: at enrollment
UPDRS part III and IV
evaluation of motor symptoms only for subjects with parkinson's disease or parkinsonisms
Measured: at enrollment
Hoehn and Yahr Scale
evaluation of clinical status only for subjects with parkinson's disease
Measured: at enrollment
NON-MOTOR SYMPTOMS SCALE
evaluation of non motor symptoms only for subjects with parkinson's disease
Measured: at enrollment
Functional Rating Scale-Revised (ALSFRS-R)
evaluation of disability only for subjects with ALS
Measured: at enrollment
MONTREAL COGNITIVE ASSESSMENT (MOCA)
Cognitive screening test for all except control subjects
Measured: at enrollment
denomination test of SAND
denomination of visual stimuli for all subjects except control cases
Measured: at enrollment
semantic, phonemic and alternate fluency Test
semantic, phonemic and alternate fluency Test for all subjects except control cases
Measured: at enrollment
TRAIL MAKING TEST part A and B
evaluation of attentional skills for all subjects except control cases
Measured: at enrollment
STROOP TEST
evaluation of inhibitory control for all subjects except control cases
Measured: at enrollment
REY'S 15-WORD TEST
evaluation of long term memory for all subjects except control cases
Measured: at enrollment
REY OSTERRIETH COMPLEX FIGURE
evaluation of visuospatial skills for all subjects except control cases
Measured: at enrollment
FACE TEST
evaluation of ability to recognize mental states of others for all subjects except control cases
Measured: at enrollment
NEUROPSYCHIATRICH INVENTORY (NPI)
interview assessing behavioral of others for all subjects except control cases
Measured: at enrollment
FRONTAL ASSESSMENT BATTERY (FAB)
evaluation of executive functions; for all subjects except control cases
Measured: at enrollment
MINIMENTAL STATE EXAMINATION (MMSE)
cognitive screening only for subjects with ADD and with Mild Cognitive Impairment (MCI)
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start14 Feb 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DisordersStudies 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
- Prospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cagliari
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875739
- Sponsor's protocol ID
- SANDY - POC
- Acronym
- SANDY
- Status last verified
- Oct 2024
- First submitted
- 7 Mar 2025
- Last updated
- 13 Mar 2025
- 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Method in SAliva Samples for the Early Differential Diagnosis of High-impact NeuroDegenerative Diseases Through Raman Spectroscopy
- ClinicalTrials.gov ID
- NCT06875739
- Acronym / sponsor ID
- SANDY / SANDY - POC
- Conditions
- Neurodegenerative Disorders, Parkinson Disease, Alzheimer Disease, Parkinsonian Disorders, Fronto-temporal Dementia, Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- University of Cagliari
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 13 Mar 2025 (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.
The aim of the study is to validate a salivary test that allows for rapid and accurate objective diagnosis in the context of neurodegenerative diseases, a complex of diseases that includes Alzheimer's Dementia, Frontotemporal Dementia, Parkinson's Disease, Atypical Parkinsonisms, and Amyotrophic Lateral Sclerosis. In particular, the study aims to validate the salivary method against methods already in use (CSF method) or better studied (blood-based method) to allow early recognition of the disease condition and a distinction between the various diseases in order to receive appropriate therapy when possible.
In fact, the term neurodegenerative diseases is a broad term that includes disorders characterized by predominantly cognitive, motor, or mixed disorders for which early and accurate diagnosis of the disease is often difficult given also the variability with which these diseases can present. Ab initio recognition of a specific neurodegenerative disease would allow better pharmacological management of this disorder and facilitate the planning of care and rehabilitation interventions. In general, the recognition of neurodegenerative diseases could be facilitated by the use of a biomarker, which is a biological indicator that can be related to the onset or development of a disease. For this reason, it is necessary to compare the biomarker assay of patients with that of controls, so you were asked to participate as a "Control Subject" precisely because you do not have neurodegenerative disease.
Participation in the study involves, in addition to the collection of clinical-demographic data, the performance of a cognitive screening test to attest that your cognitive performance is in the normal range and the collection of biological blood and salivary samples, to be compared with those of participants with neurodegenerative diseases. Apolipoprotein E (ApoE) polymorphism study will be performed on the blood. A genetic polymorphism is a variation in the DNA sequence present in at least 1% of the population, the determination of ApoE polymorphism will allow to define a His genetic characteristic related to a higher or lower risk of developing Alzheimer's Disease. Two specific biomarkers, called neurofilament light chain (NfL) and gliofibrillary acidic protein (GFAP), namely a marker of neurodegeneration and one of neuroinflammation, will also be assayed on blood. Analysis of some inflammatory proteins called cytokines will also be performed.
On saliva, the biochemical composition will be evaluated with the analysis of particles present within it called vesicles by a method called Raman Spectroscopy, and the assay of specific biomarkers called NfL and GFAP will also be performed on saliva. The diagnosis of pathology made according to clinical diagnostic criteria and supported, when necessary, by the presence of recognized biomarkers (molecular imaging/liquid markers) will be used as a reference to evaluate the diagnostic capabilities of salivary methodology to detect different pathologies and to differentiate a pathological condition from Controls. Finally, the study will also include a comparison of salivary study methods on a group of people who are at a very early stage of disease, in order to detect whether the study performed with portable instrumentation is as good a method as that with laboratory instrumentation. In fact, the use of portable instrumentation would make it even easier to acquire a biomarker quickly directly from the clinic.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control subjects | – | –They are subjects admitted to IRCCS Don Gnocchi Florence in the cardiology, pulmonology, and orthopedics departments who have no neurological symptoms or diagnosis of neurological or psychiatric diseases, in the absence of positive family history (relatives I and II degree) for NDDs. Control subjects should be in a clinically stable condition at inclusion, and will be enrolled at least 15 days after the acute event causing hospitalization. |
| cases | – | –They are individuals with a diagnosis of alzheimer's dementia, diagnosis of fronto-temporal dementia(behavioral variant), diagnosis of Parkinson's disease, clinical diagnosis of Parkinsonisms, and clinical diagnosis of amyotrophic lateral sclerosis. |
| prodromal cases | – | –Subjects with Parkinson's or Alzheimer's disease or Frontotemporal dementia (behavioral variant) in the prodromal stage according to Berg's criteria. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NDDs will be recruited from participating centers through enrollment. We plan to recruit at least 52 subjects per experimental group (52 ADDs, 52 FTDs, 52 PDs, 52 APs, 52 ALS) and 50 CTRLs. An additional 50 prodromal cases belonging to the PD, FTD behavioral variant, and AD categories.
Key inclusion criteria (18 listed)
- FOR ALL SUBJECTS: between 60 and 85 years old
- ADD: diagnosis of dementia due to AD according to clinical criteria and supported by amyloid biomarkers (biomarkers in CSF or brain PET scan with amyloid-specific tracer) according to the definition biological or neurochemical definition of disease.
- FTD: diagnosis of FTD-bv (behavioral variant) according to current clinical criteria.
- PD: diagnosis according to MDS criteria; stable drug treatment (last 4 weeks).
- APs: clinical diagnosis of Progressive Supranuclear Palsy according to the criteria of Hoglinger 2017, Corticobasal Degeneration according to the criteria of Armostrong 2013, Multisystem Atrophy according to the criteria of Wenning 2022.
Key exclusion criteria (11 listed)
- FOR CASE
- Vascular Parkinsonism and other forms of secondary Parkinsonism such as drug-induced, other known or suspected causes (metabolic, brain tumor, etc.).
- MoCA<15 for subjects with PD
- cases with validated biomarkers (CSF and PET) in diagnostic conflict.
- FOR ALL SUBJECTS
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
Cumulative Illness Rating Scale (CIRS)
Time frame: at enrollment
it's a scale that records the comorbidity
Neurological Clinical informations
Time frame: at enrollment
Presence/absence of symptoms/signs such as presence of speech disorder, hearing loss, low vision, dysphagia, oculomotricity disorder, disorientation, decreased insight, fatuity, perseveration/affacceleration, dx/sn recognition inability, gait disorder, instability/falls, neglect, ideomotor apraxia, signs of frontal release, rigidity/spasticity, bradykinesia, tremor or other involuntary movements, signs of first or second motor neuron, need for use of aids/presence of medical aids.
Genetic test
Time frame: at enrollment
genetic testing will lead in NDDs and CTRL to the determination of the ApoE polymorphism (categorical variable). In NDDs, diagnostic investigation will aim to confirm/exclude a mutation in one of the disease-causing genes (APP, PS1, PS2, MAPT, PGRN, C9ORF72, SOD 1, TARDBP, VCP) in accordance with the pathological phenotype
Plasma test
Time frame: at enrollment
NfL and GFAP assay result on plasma (continuous numeric variables)
Salivary test
Time frame: at enrollment
results of NfL and GFAP assay on saliva (continuous numeric variables)
nerological objective examination checklist
Time frame: at enrollment
presence/absence of symptoms/signs such as presence of speech disorder, hearing impairment, low vision, dysphagia, oculomotor disorder, disorientation, decreased insight, fatuity, perseveration/affacility, dx/sn recognition inability, gait disorder, instability/falls, neglect, ideomotor apraxia, signs of frontal release, rigidity/spasticity, bradykinesia, tremor or other involuntary movements, signs of first or second motor neuron,need for use of aids/presence of medical aids (categorical variables)
UPDRS part III and IV
Time frame: at enrollment
evaluation of motor symptoms only for subjects with parkinson's disease or parkinsonisms
Hoehn and Yahr Scale
Time frame: at enrollment
evaluation of clinical status only for subjects with parkinson's disease
NON-MOTOR SYMPTOMS SCALE
Time frame: at enrollment
evaluation of non motor symptoms only for subjects with parkinson's disease
Functional Rating Scale-Revised (ALSFRS-R)
Time frame: at enrollment
evaluation of disability only for subjects with ALS
MONTREAL COGNITIVE ASSESSMENT (MOCA)
Time frame: at enrollment
Cognitive screening test for all except control subjects
denomination test of SAND
Time frame: at enrollment
denomination of visual stimuli for all subjects except control cases
semantic, phonemic and alternate fluency Test
Time frame: at enrollment
semantic, phonemic and alternate fluency Test for all subjects except control cases
TRAIL MAKING TEST part A and B
Time frame: at enrollment
evaluation of attentional skills for all subjects except control cases
STROOP TEST
Time frame: at enrollment
evaluation of inhibitory control for all subjects except control cases
REY'S 15-WORD TEST
Time frame: at enrollment
evaluation of long term memory for all subjects except control cases
REY OSTERRIETH COMPLEX FIGURE
Time frame: at enrollment
evaluation of visuospatial skills for all subjects except control cases
FACE TEST
Time frame: at enrollment
evaluation of ability to recognize mental states of others for all subjects except control cases
NEUROPSYCHIATRICH INVENTORY (NPI)
Time frame: at enrollment
interview assessing behavioral of others for all subjects except control cases
FRONTAL ASSESSMENT BATTERY (FAB)
Time frame: at enrollment
evaluation of executive functions; for all subjects except control cases
MINIMENTAL STATE EXAMINATION (MMSE)
Time frame: at enrollment
cognitive screening only for subjects with ADD and with Mild Cognitive Impairment (MCI)
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 13 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neurodegenerative Disorders and Parkinson Disease, run by Fondazione Don Carlo Gnocchi ETS 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 18 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 13 Mar 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Illness Rating Scale (CIRS) (time frame: at enrollment). The study lists 21 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 13 Mar 2025.