MCINCT07553117
Accexible Speech Analysis for MCI Detection and Monitoring in Colombia
An observational study of MCI, run by Accexible at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- MCI
- What is being tested?
- Accexible
- Type of treatment
- Medical device
- How many people
- 114 participants
- Where
- 1 siteColombia
- Study dates
- 22 May 2022to 17 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged >60 years attending in-person primary care consultations within the EPS Sanitas network (Bogotá, Colombia).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Accexible
- Keywords
- MCI, machine learning, screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccexibleDevice
Speech Analysis Tool
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start22 May 2022
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accexible
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundación Universitaria Sanitas (UNISANITAS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553117
- Sponsor's protocol ID
- 023-22-UNV
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07553117
- Acronym / sponsor ID
- 023-22-UNV
- Conditions
- MCI
- Keywords
- MCI, machine learning, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- AccexibleIndustry (pharma, biotech, devices)
- Collaborators
- Fundación Universitaria Sanitas (UNISANITAS)
- Study start
- 22 May 2022 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged >60 years attending in-person primary care consultations within the EPS Sanitas network (Bogotá, Colombia).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccexibleSpeech Analysis Tool | Device | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MCI, run by Accexible at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of acceXible compared to MoCA for MCI detection (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.