CClinicalTrials.gg
CompletedNCT07553117Updated May 8, 2026

Accexible Speech Analysis for MCI Detection and Monitoring in Colombia

An observational study in MCI, sponsored by Accexible. Completed at 1 site in Colombia. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Accexible · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
114
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • MCI

Keywords

  • MCI
  • machine learning
  • screening
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In context

Lead sponsor

Accexible is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
114 participants (actual)
Patient registry
No

Interventions

  • DeviceAccexible

    Speech Analysis Tool

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What researchers measure

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.

    Time frame: Baseline

07

Study locations

1 site
  • Fundación Universitaria Sanitas
    Bogotá, 110911, Colombia
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07553117
Lead sponsor
Accexible
Collaborators
Fundación Universitaria Sanitas (UNISANITAS)
Responsible party
Sponsor
First posted
Apr 27, 2026
Start date
May 22, 2022
Primary completion
Jun 17, 2024
Completion
Jun 17, 2024
Last update
May 8, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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