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

NCT ID: NCT05380297

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-12-31

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.

Conditions

Mild Cognitive Impairment; Dementia

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Speech analysis

Speech analysis to detect and monitor mild cognitive impairment

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Accexible

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

País Vasco

País Vasco, Basque Country, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Rosa Maria Martín Gonzálvez

Role: CONTACT

ROSAMARIA.MARTINGONZALVEZ@osakidetza.eus

Facility Contacts

Rosa María Martín Gonzálvez

Role: primary

Other Identifiers

PS2020056

Identifier Type: -

Identifier Source: org_study_id