Clinical Trial

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

Study acronym: DIADEMA
Active, Not Recruiting
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Record status
This record was last updated March 19, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-10.
Trial Details
NCT Number NCT06877182
Lead Sponsor IRCCS SYNLAB SDN
Collaborators: UNINA, UNITO, Ospedale Fate bene Fratelli di Brescia
Conditions Alzheimer Disease, Dementia
Enrollment 80,000 participants
Start Date 2024-08-30
Primary Completion 2025-12-30 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-19