Clinical Trial

Accexible Speech Analysis for MCI Detection and Monitoring in Colombia

Completed
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Summary
Mild Cognitive Impairment (MCI) is frequently underdiagnosed due to its subtle clinical presentation. This study evaluates the diagnostic performance of AcceXible, a speech analysis-based machine learning platform, compared to the Montreal Cognitive Assessment (MoCA) for MCI detection and monitoring in Colombian patients. A diagnostic test accuracy study will be conducted within a primary care setting (EPS Sanitas), including prior validation of the AcceXible protocol in the Colombian healthcare context. The study pursues two primary aims: (1) to validate the AcceXible tool in a Colombian population, and (2) to demonstrate that AcceXible achieves high diagnostic accuracy for early MCI detection and longitudinal monitoring relative to the MoCA.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-21.
Trial Details
NCT Number NCT07553117
Lead Sponsor Accexible
Collaborators: Fundación Universitaria Sanitas (UNISANITAS)
Conditions MCI
Enrollment 114 participants
Start Date 2022-05-22
Primary Completion 2024-06-17 (estimated)
Study Completion 2024-06-17 (estimated)
Updated on ClinicalTrials.gov 2026-05-08