A case-control clinical trial on the diagnostic performance for Alzheimer’s Disease of a deep learning-based classification system using brain magnetic resonance imaging

Objective To investigate diagnostic performance of a deep learning-based classification system using structural brain MRI (DLCS) for Alzheimer’s disease (AD). Methods A single-center, case-control clinical trial was conducted. T1-weighted brain MRI scans of 188 patients with mild cognitive impairment or dementia due to AD and 162 cognitively normal controls were retrospectively collected. The patients were amyloid beta (Aβ)-positive, whereas the controls were Aβ-negative, on 18F-florbetaben positron emission tomography. Sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve were calculated to evaluate the performance of DLCS in the classification of Aβ-positive AD patients from Aβ-negative controls. Results The DLCS was excellent in classifying AD patients from normal controls; sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve for AD were 85.6% (95%CI, 79.8–90), 90.1% (95%CI, 84.5–94.2), 91.0% (95%CI, 86.3–94.1), 84.4% (95%CI, 79.2–88.5), and 0.937 (95%CI, 0.911–0.963), respectively. Conclusion The DLCS shows promise in clinical settings where it may improve early detection of AD in any individual who has undergone an MRI scan regardless of purpose. Trial registration: Korean Clinical Trials Registry, KCT0004758. Registered 21 February 2020, https://cris.nih.go.kr/cris/search/detailSearch.do/17665.