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AcceXible Speech Analysis for MCI Detection in Colombia NCT07553117

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Summary

This NCT07553117 observational study, registered April 27, 2026, evaluates the diagnostic performance of AcceXible, a speech analysis-based machine learning platform, for detecting Mild Cognitive Impairment (MCI) in Colombian patients at EPS Sanitas primary care settings. The study pursues two primary aims: validating the AcceXible tool in a Colombian population and demonstrating high diagnostic accuracy relative to the Montreal Cognitive Assessment (MoCA) for early MCI detection and longitudinal monitoring. The study is conducted by clinical investigators within Colombia's healthcare system and represents a diagnostic test accuracy study in a primary care setting.

“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.”

NIH , verbatim from source
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ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

This clinical trial registration documents an observational diagnostic accuracy study evaluating AcceXible, a speech analysis-based machine learning platform, against the Montreal Cognitive Assessment for Mild Cognitive Impairment detection in Colombian patients. The study will be conducted at EPS Sanitas, a Colombian primary care provider, and includes prior validation of the AcceXible protocol in the Colombian healthcare context. Two primary aims are pursued: validating the tool in the target population and demonstrating high diagnostic accuracy for early detection and longitudinal monitoring. Clinical investigators conducting MCI research and healthcare providers in Colombia may find this study relevant for understanding emerging AI-based diagnostic approaches in primary care settings.

Archived snapshot

Apr 27, 2026

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← ClinicalTrials.gov Studies

Accexible Speech Analysis for MCI Detection and Monitoring in Colombia

Observational NCT07553117 Kind: OBSERVATIONAL Apr 27, 2026

Abstract

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.

Conditions: MCI

Interventions: Accexible

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Last updated

Classification

Agency
NIH
Published
April 27th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
3345 Medical Device Manufacturing 5112 Software & Technology
Activity scope
Diagnostic device evaluation Clinical trial research AI-based screening
Geographic scope
Colombia CO

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Topics
Healthcare Artificial Intelligence

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