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OpenTrials
Completed

NCT Number: NCT05534958

UK Validation of the Automated "AcceXible" Speech Analysis Software

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.

The present study has the objective of validating a digital method for detection and follow-up of patients with mild cognitive impairment (MCI) or dementia in a memory clinic setting.

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Key information

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cornwall Partnership NHS Foundation Trust

Cornwell, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients:

  • Adult patients 55+ years of age with suspected MCI or diagnosis of dementia referred into secondary care memory clinic by their General Practitioner.
  • Have English as first language (able to speak and understand verbal messages).
  • Patients must have agreed to participate in the study and have voluntarily signed the informed consent.

Inclusion criteria

for healthy volunteers:

  • Healthy older adults (55+ years of age), without a diagnosis neurological, or psychiatric disorders or any clinical evidence of cognitive decline.
  • Have English as first language (able to speak and understand verbal messages).
  • Controls must have agreed to participate in the study and have voluntarily signed the informed consent.

Exclusion criteria

for patients:

  • 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.
  • To be unable to give informed consent to participate in the study.

Exclusion criteria

for healthy volunteers:

  • Objective evidence of significant cognitive decline in any one domain.
  • Score of <88 on ACE-III cognitive testing.

Treatment and study plan

AcceXible

Device

Speech Analysis

Primary outcomes

  1. Diagnostic performance of Accexible's digital screening battery

    Time frame: An average of 1 year

    Measure the odds that a patient has MCI or dementia measured by vocal biomarkers

Secondary outcomes

  1. Correlation of Accexible's test battery with the ACE III

    Time frame: An average of 1 year

    Comparison of Accexible's test battery with ACE III diagnostic predictive value at various cut-off points (e.g. 82 and 88 for ACE III)

Sponsors and collaborators

Lead sponsor

Accexible

Industry

Collaborators

  • Cornwall Partnership NHS Foundation Trust

Registry information

Official study title

Assessing the Diagnostic Accuracy of a Three One-minute Tests of Verbal Fluency, Using Artificial Intelligence, in Detecting Mild Cognitive Impairment and Early Dementia.

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 10, 2022
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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