Short-term Automated Longitudinal Analysis of Speech and Language in Cognitive Impairment

March 24, 2026 updated by: Accexible

"Análisis Longitudinal Del Habla y Seguimiento a Corto Plazo de Las Facultades Cognitivas de Personas Mediante Una Serie de Pruebas: Lista de Palabras CERAD, Repite Los dígitos en Orden Inverso, TMTA-B, Prueba Del Reloj, Fluidez fonémica, comprensión Verbal Relaciones semánticas, y semánticas Alternas".

Validate speech analysis AI models:

  • To contrast the accuracy of acceXible's platform as a screening tool in the detection of people with cognitive impairment and mild dementia.
  • To evaluate the correlation between automatically analyzed linguistic variables and a combination of standard measures of cognition.
  • To assess short-term variability in language ability among older adults, and to assess which aspects of language vary during the study period.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Madrid, Madrid, Spain, 28006
        • Centro de Prevención de Deterioro Cognitivo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult patients 55+ years of age with suspected MCI or diagnosis of dementia and obtains a score greater than 20 on the MMSE.
  • Patients must have agreed to participate in the study and have voluntarily signed the informed consent.
  • (Healthy) Participants without a diagnosis neurological, or psychiatric disorders. Or taking medication that can affect cognitive abilities.

Exclusion Criteria

  • To have received a diagnosis of a significant psychiatric disorder or other cognitive impairment not due to neurodegeneration.
  • To have significant vision problems that would affect the ability to perceive visual stimuli.
  • To have significant hearing problems that would affect the ability to understand verbal cues.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-post variability of normal, MCI and dementia at both points of the study.
Time Frame: Change from the baseline cognitive function at 9 months.
Through standard deviation of normal subjects, MCI and dementia, variations in language are measured by considering MMSE scores and the most significant variables of accexible's tests (image description test, phonetic verbal fluency test and semantic verbal fluency test).
Change from the baseline cognitive function at 9 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between cognitive tests and language variables obtained by the platform.
Time Frame: Every 6 to 9 months
Correlation between: Standard measures of cognition (e.g., MMSE score) + behavioral and psychiatric symptoms of mild cognitive impairment and language.
Every 6 to 9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accexible's model performance.
Time Frame: Every 6 to 9 months
Percentage of patients classified correctly compared to the total number of sick patients, visualized at the ROC curve that allows to see the accuracy against the recall of the classifier. To contrast the accuracy of AcceXible's platform as a screening tool in the detection of people with cognitive impairment and mild dementia, a detection model has been developed from the analysis of the participants, acoustic, linguistic and semantic variables have been considered as well as audio characteristics.
Every 6 to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

March 22, 2022

Study Completion (Actual)

March 22, 2022

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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