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OpenTrials
Completed

NCT Number: NCT05380297

Validation of acceXible's Automated Speech Analysis Method for the Early Detection and Monitoring of Patients With Mild Impairment or Dementia in Primary Care

Dementia, especially dementia caused by Alzheimer's disease, is considered one of the most severe health problems of our time. It is currently known that the disease begins many years before clinical symptoms appear. The sooner the patient is diagnosed, the sooner the patient will be in a position to prevent further deterioration.

A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness.

Thus, the purpose of this study is to validate speech analysis AI models.

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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

País Vasco

País Vasco, Basque Country, 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

Device

Speech analysis to detect and monitor mild cognitive impairment

Primary outcomes

  1. Vocal biomarkers to assess pre-post variability of normal, MCI and dementia at both point of the study.

    Time frame: Change from the baseline cognitive function at 9 months.

    Standard deviation of normal subjects, MCI and dementia to measure variations in language by using vocal biomarkers.

Secondary outcomes

  1. Correlation between standard cognitive test (MMSE) and linguistic variables obtained by vocal biomarkers.

    Time frame: Through study completion, an average of 1 year.

    With a 95% confidence interval, the correlation between standard cognitive test (MMSE score) and each of the linguistic variables is quantified.

Other outcomes

  1. Change of economic implications of accexible's use in a primary care center.

    Time frame: Through study completion, an average of 1 year.

    Percentage of expenditure when using the platform.

Sponsors and collaborators

Lead sponsor

Accexible

Industry

Registry information

Official study title

Validación Del método de análisis Automatizado Del Habla "AcceXible" Para la detección Temprana y Seguimiento de Pacientes Con Deterioro Cognitivo Leve o Demencia en atención Primaria.

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 18, 2022
Registry last updated
Apr 1, 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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