Novel Neuroradiological Workflow for the Assisted DIAgnosis and Management of DEMentia with Artificial Intelligence (DIADEMA)

March 14, 2025 updated by: IRCCS SYNLAB SDN
Identifying, screening and monitoring individuals at risk of Alzheimer's disease (AD) and dementia is a formidable challenge. Neuroimaging, and in particular magnetic resonance imaging (MRI), is crucial to detect structural neurodegeneration. However, current quantification tools are mainly limited to research contexts and produce non-standardised results. DIADEMA will build a systematic and standardised workflow to support neuro(radio)logical diagnosis. By combining artificial intelligence (AI) and machine learning (ML) the investigators will significantly enhance the clinical diagnosis of AD in neuroradiology. The investigator's main hypothesis is that an efficient workflow and associated higher diagnostic accuracy will substantially reduce healthcare costs, support clinical decision-making, provide second-opinion tools and improve patient care. This dual advance will have a profound impact on the healthcare system, marking an important step in the fight against Alzheimer's disease and dementia.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80146
        • Irccs Synlab Sdn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who perform brain magnetic resonance during the last 20 years

Description

Inclusion Criteria:

  • patients who perform brain magnetic resonance during the last 20 years

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of the neuroradiological workflow performance
Time Frame: 1-36 month
ROC curves
1-36 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS SYNLAB SDN

Collaborators

UNINA
UNITO
Ospedale Fate bene Fratelli di Brescia

Investigators

  • Principal Investigator: Marco Aiello, Irccs Synlab Sdn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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