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OpenTrials
Completed

NCT Number: NCT05340218

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

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.

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Key information

Conditions

Mild Cognitive Impairment Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Prevención de Deterioro Cognitivo

Madrid, 28006, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Speech analysis

Other

Speech analysis to detect and monitor mild cognitive impairment

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Accexible

Industry

Registry information

Official study title

"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".

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2022
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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