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

Enrolling by invitationOBSERVATIONAL
Enrollment

340

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2028

Conditions
Dementia (Diagnosis)Alzheimer Dementia (AD)Vascular Dementia (VaD)Lewy Body Dementia (LBD)Frontotemporal Dementia (FTD)Mild Cognitive Impairment (MCI)Depression - Major Depressive Disorder
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"

Trial Locations (1)

4000

Zealand University Hospital, Roskilde

All Listed Sponsors
collaborator

DemensAI ApS (private tech partner, Denmark)

UNKNOWN

lead

Zealand University Hospital

OTHER

NCT07200739 - Speech-Based Artificial Intelligence for Detection of Dementia in Danish Patients | Biotech Hunter | Biotech Hunter