Evaluation of SCALE PET Software for Quantitative Brain PET Analysis in Alzheimer's Disease

The goal of this study is to learn if medical image analysis software, Neurophet SCALE PET, can enhance readers' amyloid beta positivity performance in people with Alzheimer's Disease. The main question it aims to answer is: Does the use of medical image analysis software assistance result in a statistically significant difference in readers' sensitivity and specificity for the classification of amyloid-β (Aβ) positivity? Four readers will interpret amyloid PET images in two sessions (with and without software assistance), separated by a 4-week washout period, and will record Aβ positivity and diagnostic confidence using predefined rating scales.

NCT Number	NCT07417540
Lead Sponsor	NEUROPHET Collaborators: Ajou University School of Medicine
Conditions	Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI)
Enrollment	190 participants
Start Date	2025-06-02
Primary Completion	2025-11-17 (estimated)
Study Completion	2025-11-17 (estimated)
Updated on ClinicalTrials.gov	2026-02-18