NCT05340218

Brief Summary

Validate speech analysis AI models:

  • To contrast the accuracy of acceXible's platform as a screening tool in the detection of people with cognitive impairment and mild dementia.
  • To evaluate the correlation between automatically analyzed linguistic variables and a combination of standard measures of cognition.
  • To assess short-term variability in language ability among older adults, and to assess which aspects of language vary during the study period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

March 29, 2022

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pre-post variability of normal, MCI and dementia at both points of the study.

    Through standard deviation of normal subjects, MCI and dementia, variations in language are measured by considering MMSE scores and the most significant variables of accexible's tests (image description test, phonetic verbal fluency test and semantic verbal fluency test).

    Change from the baseline cognitive function at 9 months.

Secondary Outcomes (1)

  • Correlation between cognitive tests and language variables obtained by the platform.

    Every 6 to 9 months

Other Outcomes (1)

  • Accexible's model performance.

    Every 6 to 9 months

Interventions

Speech analysis to detect and monitor mild cognitive impairment

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Prevención de Deterioro Cognitivo

Madrid, Madrid, 28006, Spain

Location

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous 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

April 22, 2022

Study Start

January 1, 2019

Primary Completion

March 22, 2022

Study Completion

March 22, 2022

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations