Clinical trial NCT05534958: UK Validation of the Automated "AcceXible" Speech Analysis Software
Official 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment and Dementia
Lead sponsor: Accexible
Sponsor class: INDUSTRY
Collaborators: name: Cornwall Partnership NHS Foundation Trust
First posted: 2022-09-10
Enrollment: 248
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Diagnostic performance of Accexible's digital screening battery
timeFrame: An average of 1 year
Secondary outcomes:
measure: Correlation of Accexible's test battery with the ACE III
timeFrame: An average of 1 year
Other outcomes:
Locations:
city: Cornwell
country: United Kingdom
facility: Cornwall Partnership NHS Foundation Trust
Study officials:
References: