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

NCT05380297 | Completed DMC

• 1 other identifier: PS2020056
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Through study completion, an average of 1 year.

Other Outcomes (1)

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

  Through study completion, an average of 1 year.

Interventions

Speech analysis DEVICE

Speech analysis to detect and monitor mild cognitive impairment

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Accexible: lead

Study Sites (1)

País Vasco

País Vasco, Basque Country, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: May 18, 2022
• Study Start: May 17, 2021
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)