Accexible Speech Analysis for MCI Detection and Monitoring in Colombia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07553117

Enrollment

114

Registered

2026-04-27

Start date

2022-05-22

Completion date

2024-06-17

Last updated

2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MCI

Keywords

MCI, machine learning, screening

Brief 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.

Interventions

DEVICEAccexible

Speech Analysis Tool

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy of acceXible compared to MoCA for MCI detection	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.

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026