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Clinical Trials/NCT05534958
NCT05534958
Completed
Not Applicable

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

Accexible2 sites in 1 country221 target enrollmentNovember 18, 2022

Overview

Phase
Not Applicable
Intervention
Accexible
Conditions
Mild Cognitive Impairment and Dementia
Sponsor
Accexible
Enrollment
221
Locations
2
Primary Endpoint
Diagnostic performance of Accexible's digital screening battery
Status
Completed
Last Updated
9 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 18, 2022
End Date
December 31, 2024
Last Updated
9 days ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Accexible
Responsible Party
Sponsor

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.

Arms & Interventions

Healthy

Intervention: Accexible

Mild Cognitive Impairment

Intervention: Accexible

Early Dementia

Intervention: Accexible

Outcomes

Primary Outcomes

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

  • Correlation of Accexible's test battery with the ACE III(An average of 1 year)

Study Sites (2)

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