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

NCT06877182 | Active Not Recruiting

• 1 other identifier: 1/24
• Study Type: observational
• Target: 80,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Dementia

Keywords

Neuroimaging; Artificial Intelligence (AI); Dementia; Assisted Diagnosis; Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcomes (1)

• Improvement of the neuroradiological workflow performance

  ROC curves

  1-36 month

Interventions

Magnetic Resonance Imaging with Contrast DIAGNOSTIC_TEST

To evaluate the possibility to improve the neuroradiologic workflow with AI models

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who perform brain magnetic resonance during the last 20 years

You may qualify if:

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

Sponsors & Collaborators

• IRCCS SYNLAB SDN: lead
• UNINA: collaborator
• UNITO: collaborator
• Ospedale Fate bene Fratelli di Brescia: collaborator

Study Sites (1)

Irccs Synlab Sdn

Naples, 80146, Italy

Location

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MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Marco Aiello

  IRCCS SYNLAB SDN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: August 30, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)