Neurodegenerative DiseasesPREDICTIVENCT07870070
Functionalized Point of Care and 3D Printed Dental Aligners as Devices for Early Detection of Neurodegenerative Diseases
An observational study of Neurodegenerative Diseases and Alzheimer's Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The treatment of dementias of neurodegenerative origin is currently limited to symptomatic drugs that are unable to interfere with the underlying mechanisms of neurodegeneration, as the pathological processes leading to dementia begin decades before the onset of clinical symptoms. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases, Alzheimer's Disease
- How many people
- 256 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 31 Jan 2027
- How long will I take part?
- 6 Months
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 78 AD patients, 50 Dementia patients (FTD, DLB), 50 MS patients, 78 healthy controls
Who may be able to join
- age >50 years
- diagnosis: Alzheimer's disease
Who cannot join
- age <50 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identificazione Del Profilo di microRNA Salivari Nella Malattia di Alzheimer e Sviluppo di un Nuovo Metodo di Rilevamento Basato su Biosensori
The treatment of dementias of neurodegenerative origin is currently limited to symptomatic drugs that are unable to interfere with the underlying mechanisms of neurodegeneration, as the pathological processes leading to dementia begin decades before the onset of clinical symptoms. In this context, biomarkers for the diagnosis of Alzheimer's disease (AD), the most common form of dementia, are currently available but are either invasive, requiring lumbar puncture, or very expensive, such as PET imaging with amyloid and, potentially, tau tracers. Their widespread application across different clinical settings is therefore impractical.
Accordingly, one of the major challenges in this field is the identification of peripheral screening biomarkers with a high negative predictive value (NPV), capable of identifying individuals who are negative for disease-associated biomarkers and can therefore be classified as healthy. Among the most promising biomarkers for neurodegenerative diseases are microRNAs (miRNAs), small non-coding RNA molecules.
Read more
This study is part of the Italian National Recovery and Resilience Plan (PNRR) project on high-impact Non-Communicable Chronic Diseases (MCnT2), Project Code PNRR-POC-2023-12377354, funded by the Italian Ministry of Health/European Union - Next Generation EU - PNRR M6C2, Investment 2.1, "Enhancement and Strengthening of Biomedical Research within the Italian National Health Service." The participating institutions are Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano and Azienda Ospedaliero-Universitaria "Policlinico San Marco" di Catania.
The main working hypotheses of the funded PNRR project are the identification of miRNAs that are dysregulated in patients with AD compared with age-matched healthy individuals and patients with non-AD conditions, and the development of a solution-based sensor for the simplified detection of the identified miRNAs. The sensor will exploit the biochemical methodology developed in Italian Patent No. IT102022000014740 (filed on July 13, 2022), which is capable of measuring the levels of specific enzymes in saliva.
The project is structured into three Work Packages (WPs):
WP1: Identification and validation of candidate miRNAs and calculation of their negative predictive value (NPV).
WP2: Development and optimization of the solution-based sensor and assessment of its ability to detect the findings identified in WP1 using a simpler methodology.
WP3: Testing of the sensor in a cohort of patients with AD and controls across different clinical settings, including neurological and dental clinics, in order to assess its applicability in real-world clinical practice.
In this study, we aim to:
identify the most significantly dysregulated miRNAs in the saliva of patients with AD (WP1); and develop and optimize a solution-based gold nanoparticle biosensor capable of detecting candidate miRNAs in saliva samples from both patients with AD and healthy individuals (WP2).
- Conditions
- Neurodegenerative Diseases, Alzheimer's Disease
- Keywords
- Dementia, MCI, Biomarkers, saliva, miRNA
- Medical subject headings
- Neurodegenerative Diseases, Alzheimer Disease, Dementia
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 |
|---|---|---|
| Discovery: 1) 28 patients with prodromal AD | saliva collection | |
| Discovery: 2) 28 healthy controls | saliva collection | |
| Validation 3) 50 AD patients | saliva collection | |
| Validation 4) 50 other dementia patients (FTD, DLB) | saliva collection | |
| Validation 5) 50 MS patients | saliva collection | |
| Validation 6) 50 healthy controls | saliva collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNAs identification
Identification of the most significantly dysregulated miRNAs, based on statistically significant differences in expression, measured as log fold change, between AD patients and age-matched healthy controls
Measured: till 31 January, 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Sep 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- 256 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870070
- Sponsor's protocol ID
- PNRR-POC-2023-12377354
- Other IDs
- PNRR-POC-2023-12377354
- Acronym
- PREDICTIVE
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Serpente M, Fenoglio C, D'Anca M, Arcaro M, Sorrentino F, Visconte C, Arighi A, Fumagalli GG, Porretti L, Cattaneo A, Ciani M, Zanardini R, Benussi L, Ghidoni R, Scarpini E, Galimberti D. MiRNA Profiling in Plasma Neural-Derived Small Extracellular Vesicles from Patients with Alzheimer's Disease. Cells. 2020 Jun 10;9(6):1443. doi: 10.3390/cells9061443.
PubMed 32531989
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identificazione Del Profilo di microRNA Salivari Nella Malattia di Alzheimer e Sviluppo di un Nuovo Metodo di Rilevamento Basato su Biosensori
- ClinicalTrials.gov ID
- NCT07870070
- Acronym / sponsor ID
- PREDICTIVE / PNRR-POC-2023-12377354
- Conditions
- Neurodegenerative Diseases, Alzheimer's Disease
- Keywords
- Dementia, MCI, Biomarkers, saliva, miRNA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 13 Oct 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.
The treatment of dementias of neurodegenerative origin is currently limited to symptomatic drugs that are unable to interfere with the underlying mechanisms of neurodegeneration, as the pathological processes leading to dementia begin decades before the onset of clinical symptoms. In this context, biomarkers for the diagnosis of Alzheimer's disease (AD), the most common form of dementia, are currently available but are either invasive, requiring lumbar puncture, or very expensive, such as PET imaging with amyloid and, potentially, tau tracers. Their widespread application across different clinical settings is therefore impractical.
Accordingly, one of the major challenges in this field is the identification of peripheral screening biomarkers with a high negative predictive value (NPV), capable of identifying individuals who are negative for disease-associated biomarkers and can therefore be classified as healthy. Among the most promising biomarkers for neurodegenerative diseases are microRNAs (miRNAs), small non-coding RNA molecules.
This study is part of the Italian National Recovery and Resilience Plan (PNRR) project on high-impact Non-Communicable Chronic Diseases (MCnT2), Project Code PNRR-POC-2023-12377354, funded by the Italian Ministry of Health/European Union - Next Generation EU - PNRR M6C2, Investment 2.1, "Enhancement and Strengthening of Biomedical Research within the Italian National Health Service." The participating institutions are Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano and Azienda Ospedaliero-Universitaria "Policlinico San Marco" di Catania.
The main working hypotheses of the funded PNRR project are the identification of miRNAs that are dysregulated in patients with AD compared with age-matched healthy individuals and patients with non-AD conditions, and the development of a solution-based sensor for the simplified detection of the identified miRNAs. The sensor will exploit the biochemical methodology developed in Italian Patent No. IT102022000014740 (filed on July 13, 2022), which is capable of measuring the levels of specific enzymes in saliva.
The project is structured into three Work Packages (WPs):
WP1: Identification and validation of candidate miRNAs and calculation of their negative predictive value (NPV).
WP2: Development and optimization of the solution-based sensor and assessment of its ability to detect the findings identified in WP1 using a simpler methodology.
WP3: Testing of the sensor in a cohort of patients with AD and controls across different clinical settings, including neurological and dental clinics, in order to assess its applicability in real-world clinical practice.
In this study, we aim to:
identify the most significantly dysregulated miRNAs in the saliva of patients with AD (WP1); and develop and optimize a solution-based gold nanoparticle biosensor capable of detecting candidate miRNAs in saliva samples from both patients with AD and healthy individuals (WP2).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Discovery: 1) 28 patients with prodromal AD | – | –saliva collection |
| Discovery: 2) 28 healthy controls | – | –saliva collection |
| Validation 3) 50 AD patients | – | –saliva collection |
| Validation 4) 50 other dementia patients (FTD, DLB) | – | –saliva collection |
| Validation 5) 50 MS patients | – | –saliva collection |
| Validation 6) 50 healthy controls | – | –saliva collection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 78 AD patients, 50 Dementia patients (FTD, DLB), 50 MS patients, 78 healthy controls
Key inclusion criteria (2 listed)
- age >50 years
- diagnosis: Alzheimer's disease
Key exclusion criteria (1 listed)
- age <50 years
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
miRNAs identification
Time frame: till 31 January, 2027
Identification of the most significantly dysregulated miRNAs, based on statistically significant differences in expression, measured as log fold change, between AD patients and age-matched healthy controls
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 Oct 2026.
- Background: PubMed 32531989Serpente M, Fenoglio C, D'Anca M, Arcaro M, Sorrentino F, Visconte C, Arighi A, Fumagalli GG, Porretti L, Cattaneo A, Ciani M, Zanardini R, Benussi L, Ghidoni R, Scarpini E, Galimberti D. MiRNA Profiling in Plasma Neural-Derived Small Extracellular Vesicles from Patients with Alzheimer's Disease. Cells. 2020 Jun 10;9(6):1443. doi: 10.3390/cells9061443.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodegenerative Diseases and Alzheimer's Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site 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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
miRNAs identification (time frame: till 31 January, 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07870070, which also lists 1 linked publication.
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 Oct 2026.