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A single-center, nested case-control, pivotal trial to evaluate the efficacy of artificial intelligence-based clinical decision support system for Alzheimer’s disease using T1 weighted MR brain images

A single-center, nested case-control, pivotal trial to evaluate the efficacy of artificial intelligence-based clinical decision support system for Alzheimer’s disease using T1 weighted MR brain images

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004758
Enrollment
350
Registered
2020-02-21
Start date
2020-04-27
Completion date
Unknown
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : VUNO Med - DeepBrain AD software tells Alzheimer's disease probability from uploaded images

Sponsors

Vuno
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults over 50 years old who visited the hospital between Jan 2010 and Sep 2019 and took brain magnetic resonance imaging (T1 weighted MRI) 2) Those who are classified as Disease group or Normal group according to the following criteria - Disease group: Amyloid PET positive, and who is diagnosed with probable/possible Alzheimer's disease (AD) according to NINCDS-ADRDA criteria, or with mild cognitive impairment (MCI) according to IWG criteria on MCI - Normal group: Amyloid PET negative, and who 1) does not appeal subjective cognitive decline or 2) has no objective cognitive decline

Exclusion criteria

Exclusion criteria: 1) Patients with dementia due to other causes than Alzheimer's disease 2) Cerebral lesions that may cause cognitive deficits (e.g., space-occupying lesions, subdural lesions, or normal cerebral pressure hydrocephalus, etc.) on brain T1-weighted MR images, or severe white matter hyperintensities (grade 3 or higher) on T2 FLAIR MR images 3) The interval between the date of diagnosis (or clinical evaluation) and the date of MRI is more than one year (only for Normal group and MCI patients in Disease group) 4) A person who is considered difficult to participate in this trial, as determined by the investigators

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity

Secondary

MeasureTime frame
Area under the receiver operating characteristic curve

Countries

Korea, Republic of

Contacts

Public ContactJong Bin Bae

Seoul National University Bundang Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026