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Clinical Trials/NCT05380297
NCT05380297
Unknown
Not Applicable

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.

Accexible1 site in 1 country248 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Accexible
Enrollment
248
Locations
1
Primary Endpoint
Vocal biomarkers to assess pre-post variability of normal, MCI and dementia at both point of the study.
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
December 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Accexible
Responsible Party
Sponsor

Eligibility Criteria

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Correlation between standard cognitive test (MMSE) and linguistic variables obtained by vocal biomarkers.(Through study completion, an average of 1 year.)

Study Sites (1)

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