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OpenTrials
Completed

NCT Number: NCT07553117

Accexible Speech Analysis for MCI Detection and Monitoring in Colombia

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.

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Key information

Conditions

MCI

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundación Universitaria Sanitas

Bogotá, 110911, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to independently operate a mobile or portable device with internet connectivity and integrated microphone
  • Provision of voluntary written informed consent prior to study participation

Exclusion criteria

  • Diagnosed psychiatric disorder or cognitive impairment not attributable to neurodegenerative etiology
  • Visual impairment sufficient to preclude reading on-screen text or perceiving visual stimuli
  • Illiteracy
  • Hearing impairment sufficient to preclude comprehension of verbal instructions or detection of auditory test-onset cues

Treatment and study plan

AcceXible

Device

Speech Analysis Tool

Primary outcomes

  1. Diagnostic accuracy of acceXible compared to MoCA for MCI detection

    Time frame: Baseline

    Sensitivity and specificity of the acceXible speech-based platform relative to the MoCA (reference standard; cutoff <30 = abnormal) for detecting MCI in adults aged ≥55 years. Additional metrics: area under the ROC curve (AUC), positive and negative predictive values (PPV, NPV), and likelihood ratios.

Sponsors and collaborators

Lead sponsor

Accexible

Industry

Collaborators

  • Fundación Universitaria Sanitas (UNISANITAS)

Registry information

Official study title

Assessment of Sensitivity and Specificity of a Machine Learning System for Detection and Monitoring of Mild Cognitive Impairment (Accexible) Through Speech Analysis in a Colombian Population

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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