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 Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05380297
• Other study ID #: PS2020056
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Accexible
• Contact: Rosa Maria Martín Gonzálvez
• Email: ROSAMARIA.MARTINGONZALVEZ[@]osakidetza.eus
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

Device:
• Speech analysis
Speech analysis to detect and monitor mild cognitive impairment

Locations

Country	Name	City	State
Spain	País Vasco	País Vasco

Sponsors (1)

Lead Sponsor	Collaborator
Accexible

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of economic implications of accexible's use in a primary care center.	Percentage of expenditure when using the platform.	Through study completion, an average of 1 year.
Primary	Vocal biomarkers to assess pre-post variability of normal, MCI and dementia at both point of the study.	Standard deviation of normal subjects, MCI and dementia to measure variations in language by using vocal biomarkers.	Change from the baseline cognitive function at 9 months.
Secondary	Correlation between standard cognitive test (MMSE) and linguistic variables obtained by vocal biomarkers.	With a 95% confidence interval, the correlation between standard cognitive test (MMSE score) and each of the linguistic variables is quantified.	Through study completion, an average of 1 year.