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

Not Applicable

• Conditions: Mild Cognitive Impairment; Dementia

• Registration Number: NCT05380297
• Lead Sponsor: Accexible

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2022-03-29
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-16
• Last Update Submitted: 2022-05-16
• Study First Posted: 2022-05-18
• Last Update Posted: 2022-05-18
• Primary Completion: 2022-07
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 248

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Vocal biomarkers to assess pre-post variability of normal, MCI and dementia at both point of the study.	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 Outcome Measures

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

Trial Locations

Locations (1)

País Vasco; 🇪🇸 País Vasco, Spain