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ENROLLING BY INVITATION
NCT07200739

Speech-Based Artificial Intelligence for Detection of Dementia in Danish Patients

Sponsor: Zealand University Hospital

View on ClinicalTrials.gov

Summary

The goal of this observational study is to develop and test an artificial intelligence (AI) model that can detect signs of dementia and related conditions from speech recordings. The main question is whether a speech-based AI model can correctly tell apart people with normal memory and thinking from those with cognitive impairment. The study will also explore whether the AI can distinguish dementia from depression, separate different dementia subtypes, and identify which people with Mild Cognitive Impairment (MCI) are likely to develop dementia. Participants will complete short memory and speech tasks while being recorded. The AI model will analyze these recordings to learn patterns linked to different diagnoses. At the end of the study, its accuracy will be tested on new participants.

Official title: Development and Validation of Non-Invasive Danish Language and Speech Biomarkers for Neurodegenerative Disease Classification by Means of Automatic Speech Recognition With Artificial Intelligence (DetectAI)

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

OBSERVATIONAL

Enrollment

340

Start Date

2025-10-01

Completion Date

2028-06

Last Updated

2025-10-07

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Mini-mental State Examination

Participants will be recorded during the test in order til allow the AI to learn and analyze speech patterns.

DIAGNOSTIC_TEST

Addenbrooke's Cognitive Examination

Participants will be recorded during the test in order til allow the AI to learn and analyze speech patterns.

OTHER

Speech task - Picture Description

Participants will be asked to describe the Cookie Theft Picture from the Boston Diagnostic Aphasia Examination. The task will take 2 minutes. Participants will be recorded during the speech task in order to allow the AI to learn and analyze the speech patterns.

OTHER

Speech task - Story Retellling

Participants will be asked to retell the fairy-tale "Cinderella", based on pictures that summarize the fairy-tale. In case "Cinderella" is not known, participants are asked to tell a story with a start, a middle and an end based on the provided pictures. The task will take 4 minutes. Participants will be recorded during the speech task in order to allow the AI to learn and analyze the speech patterns.

OTHER

Fluency tasks

Two fluency tasks from the Addenbrooke's Cognitive Examination. First, the participant is asked to name as many animals as possible within 1 minutes. Next the participant is asked to name as many words starting with "S" as possible within 1 minute. Participants will be recorded during the tasks in order to allow the AI to learn and analyze speech patterns.

DIAGNOSTIC_TEST

MRI

For healthy controls an MRI will be conducted to provide comparable imaging and as part of screening to ensure they do not meet exclusion criteria (neuroradiological findings that could affect cognitive functions). For participants in the follow-up or new referral cohorts, imaging will be performed as part of the standard diagnostic battery and results will be obtained from the electronic journal.

DIAGNOSTIC_TEST

blood sampling

Healthy control participants will undergo a standard blood test panel commonly used in dementia diagnostics. The panel includes complete blood counts, inflammatory markers, kidney- and liver function markers, thyroid-stimulating hormone (TSH), vitamine B12 and folate. These tests are performed to exclude underlying medical conditions that could mimic cognitive impairment. For participants in the follow-up or new referral cohorts, blood sampling will be performed as part of the standard diagnostic battery and results will be obtained from the electronic journal.

DIAGNOSTIC_TEST

Depression screening

Performed on healthy controls to rule out depression using either the geriatric depression scale (GDS) for patients \> 65 year of age or the Major Depression Index (MDI) for patiens \<65 year of age. For participants in the follow-up or new referral cohorts, depression screening will be performed as part of the standard diagnostic battery and results will be obtained from the electronic journal.

OTHER

Somatic- and neurological examination

Healthy controls will undergo a standard somatic and neurological examination to exclude conditions that may affect cognition. This includes basic neurological assessment and clinical evaluation of general health status. For participants in the follow-up or new referral cohorts, a somatic and neurological examination will be performed as part of the standard diagnostic battery and results will be obtained from the electronic journal

Locations (1)

Zealand University Hospital

Roskilde, Region Sjælland, Denmark