CClinicalTrials.gg
CompletedNCT05534958Updated Apr 23, 2026

UK Validation of the Automated "AcceXible" Speech Analysis Software

An observational study in Mild Cognitive Impairment and Dementia, sponsored by Accexible. Completed at 1 site in United Kingdom. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Accexible · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
221
Ages
55 Years to 90 Years
Sex
All
01

Study 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.

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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Conditions studied

  • Mild Cognitive Impairment and Dementia
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In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 221 is above the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Accexible is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Sample:

Cases: 125 adult patients >55 years with suspected MCI or diagnosis of dementia referred to memory clinic.

Controls: 125 healthy adult patients >55 years without a diagnosis of MCI and without subjective cognitive complaints.

Eligibility criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
221 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy

    Device: Accexible

  • Mild Cognitive Impairment

    Device: Accexible

  • Early Dementia

    Device: Accexible

Interventions

  • DeviceAccexible

    Speech Analysis

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What researchers measure

Primary outcomes

  1. Diagnostic performance of Accexible's digital screening battery

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

    Time frame: An average of 1 year

Secondary outcomes

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

    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)

    Time frame: An average of 1 year

07

Study locations

1 site
  • Cornwall Partnership NHS Foundation Trust
    Cornwell, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05534958
Lead sponsor
Accexible
Collaborators
Cornwall Partnership NHS Foundation Trust
Responsible party
Sponsor
First posted
Sep 10, 2022
Start date
Nov 18, 2022
Primary completion
Nov 12, 2024
Completion
Dec 31, 2024
Last update
Apr 23, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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