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

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05380297
Enrollment
273
Registered
2022-05-18
Start date
2021-05-17
Completion date
2024-04-18
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Mild Cognitive Impairment

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.

Interventions

Speech analysis to detect and monitor mild cognitive impairment

Sponsors

Accexible
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026