UK Validation of the Automated "AcceXible" Speech Analysis Software

NCT05534958 | Completed

• 1 other identifier: 22/PR/0963
• Study Type: observational
• Target: 221
• 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. 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.

Conditions

Mild Cognitive Impairment and Dementia

Outcome Measures

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

  An average of 1 year

Secondary Outcomes (1)

• Correlation of Accexible's test battery with the ACE III

  An average of 1 year

Study Arms (3)

Healthy

Device: Accexible

Mild Cognitive Impairment

Device: Accexible

Early Dementia

Device: Accexible

Interventions

Accexible DEVICE

Speech Analysis

Early Dementia; Healthy; Mild Cognitive Impairment

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

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.
• To be unable to give informed consent to participate in the study.
• Objective evidence of significant cognitive decline in any one domain.
• Score of \<88 on ACE-III cognitive testing.

Sponsors & Collaborators

• Accexible: lead
• Cornwall Partnership NHS Foundation Trust: collaborator

Study Sites (1)

Cornwall Partnership NHS Foundation Trust

Cornwell, United Kingdom

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: November 18, 2022
• Primary Completion: November 12, 2024
• Study Completion: December 31, 2024
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

GB (1)