Status:
ENROLLING_BY_INVITATION
Speech-Based Artificial Intelligence for Detection of Dementia in Danish Patients
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
DemensAI ApS (private tech partner, Denmark)
Conditions:
Dementia (Diagnosis)
Alzheimer Dementia (AD)
Eligibility:
All Genders
50+ years
Brief 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 ...
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 pathway...
Eligibility Criteria
Inclusion
- Age \> 50 years
- Fluent in Danish
- Minimum 7 years of schooling
- For participants from the follow-up cohort:
- A consensus diagnosis of either AD, VaD, LBD, FTD, MCI or depression established at the memory clinic within 6 months prior to enrollment
- For participants from the healthy control cohort:
- No known cognitive impairment or affective disorder
Exclusion
- Significantly impaired vision or hearing (to the extent that the participant cannot participate in the linguistic AI analysis)
- Participants unable to give consent
- Participants from follow-up and new referrals cohort:
- MMSE score \< 16
- Participants with multiple diagnoses (eg. mixed dementia or AD with concurrent depression)
- For participants from the new referrals cohort:
- Participants falling outside of the six categories included in the study (AD, VaD, LBD, FTD, MCI, Depression)
- Participants where it is obvious at baseline that they will not fall within the above categories (can be excluded before clinical consensus diagnosis is given)
- For participants from the healthy control cohort:
- MMSE \<26 and ACE \<90
- GDS score indicating depression (6 or higher)
- Clinical, laboratory or neuroradiological findings that could affect cognitive functions
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT07200739
Start Date
October 1 2025
End Date
June 1 2028
Last Update
October 7 2025
Active Locations (1)
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1
Zealand University Hospital
Roskilde, Region Sjælland, Denmark, 4000