Trials / Enrolling By Invitation

Enrolling By InvitationNCT07200739

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

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)

Status: Enrolling By Invitation
Phase: —
Study type: Observational
Enrollment: 340 (estimated)

Sponsor: Zealand University Hospital · Academic / Other
Sex: All
Age: 50 Years
Healthy volunteers: Accepted

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.

Detailed description

Background Dementia is a growing public health challenge, and early and accurate diagnosis is essential for effective care and potential future disease-modifying treatments. Current diagnostic pathways are resource-intensive and associated with long waiting times. Speech reflects cognitive functioning, and recent international studies have shown that AI can detect dementia-related patterns in speech recordings with promising accuracy. This study aims to develop and validate a speech-based AI model in a Danish setting, providing a non-invasive and scalable screening tool for use in primary care. Phases one This protocol describes the first phase of our study which is expected to be completed in two separate phases. In phase one we seek to train an AI model to analyse speech data from participants with cognitive impairment and compare it to speech data from healthy control participants, as is detailed through this protocol. If the method is validated, we will continue to phase two. Future work In phase two we expect to conduct an external validation. The AI model analysis will be performed on 200 participants in the primary care sector referred for dementia evaluation. The results of the AI analysis will be compared against the final gold standard consensus diagnosis. Phase two will have a separate protocol which will be worked up based on the results from phase one. Elaboration of time perspective Other: Hybrid design. Most participants will be included in a cross-sectional case-control study (single speech recording). For participants with MCI, follow-up data will be collected within the study period to assess progression to dementia, allowing evaluation of the model's ability to distinguish progressive from non-progressive MCI.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2025-10-01
Primary completion: 2027-06-01
Completion: 2028-06-01
First posted: 2025-10-01
Last updated: 2025-10-07

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT07200739. Inclusion in this directory is not an endorsement.