Accexible Speech Analysis for MCI Detection and Monitoring in Colombia

NCT07553117 | Completed

• 1 other identifier: 023-22-UNV
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

MCI

Keywords

MCI; machine learning; screening

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of acceXible compared to MoCA for MCI detection

  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.

  Baseline

Interventions

Accexible DEVICE

Speech Analysis Tool

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged \>60 years attending in-person primary care consultations within the EPS Sanitas network (Bogotá, Colombia).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Accexible: lead
• Fundación Universitaria Sanitas: collaborator

Study Sites (1)

Fundación Universitaria Sanitas

Bogotá, 110911, Colombia

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 27, 2026
• Study Start: May 22, 2022
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)