Speech-Based Artificial Intelligence for Detection of Dementia in Danish Patients
NCT ID: NCT07200739
Last Updated: 2025-10-07
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
340 participants
OBSERVATIONAL
2025-10-01
2028-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Healthy Controls
n\~40
Mini-mental State Examination
Participants will be recorded during the test in order til allow the AI to learn and analyze speech patterns.
Addenbrooke's Cognitive Examination
Participants will be recorded during the test in order til allow the AI to learn and analyze speech patterns.
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.
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.
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.
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.
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.
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
New Referrals
New Referrals to the memory clinic. Diagnosis unknown at the time of enrollment. N\~200
Mini-mental State Examination
Participants will be recorded during the test in order til allow the AI to learn and analyze speech patterns.
Addenbrooke's Cognitive Examination
Participants will be recorded during the test in order til allow the AI to learn and analyze speech patterns.
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.
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.
Participants from follow-up
Participants with a clinical consensus diagnosis of either Alzheimer's dementia, Vascular dementia, Lewy body Dementia, Frontotemporal Dementia, Mild Cognitive Impairment or Depression. Diagnosis must be established in the memory clinic at ZUH within the past 6 months at the time of enrollment. N\~100
Mini-mental State Examination
Participants will be recorded during the test in order til allow the AI to learn and analyze speech patterns.
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.
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.
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.
Interventions
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Mini-mental State Examination
Participants will be recorded during the test in order til allow the AI to learn and analyze speech patterns.
Addenbrooke's Cognitive Examination
Participants will be recorded during the test in order til allow the AI to learn and analyze speech patterns.
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.
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.
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.
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.
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.
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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
50 Years
ALL
Yes
Sponsors
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DemensAI ApS (private tech partner, Denmark)
UNKNOWN
Zealand University Hospital
OTHER
Responsible Party
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Principal Investigators
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Peter Høgh, MD, PhD, Assoc Prof
Role: PRINCIPAL_INVESTIGATOR
Zealand University Hospital
Locations
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Zealand University Hospital
Roskilde, Region Sjælland, Denmark
Countries
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References
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Dargaud L, Partal A, Birn A, & Detlefsen S. N. (2023). Developing a Spontaneous Speech-based Artificial Intelligence for Alzheimer's Disease Detection. Transatlantic Telehealth Research Network (TTRN) International Scientific Conference 2023, Journal of the International Society for Telemedicine and eHealth.
Lanzi AM, Saylor AK, Fromm D, Liu H, MacWhinney B, Cohen ML. DementiaBank: Theoretical Rationale, Protocol, and Illustrative Analyses. Am J Speech Lang Pathol. 2023 Mar 9;32(2):426-438. doi: 10.1044/2022_AJSLP-22-00281. Epub 2023 Feb 15.
Li J, Song K, Zheng B, Li D, Wu X, Meng H. Leveraging Pretrained Representations with Task-related Keywords for Alzheimer's Disease Detection. arXiv preprint. 2023.
Luz S, Haider F, de la Fuente Garcia S, Fromm D, MacWhinney B. Detecting cognitive decline using speech only: The ADReSSo challenge. arXiv preprint 2021.
Luz S, Haider F, Fromm D, Lazarou I, Kompatsiaris I, Macwhinney B. An Overview of the ADReSS-M Signal Processing Grand Challenge on Multilingual Alzheimer's Dementia Recognition Through Spontaneous Speech. IEEE Open J Signal Process. 2024;5:738-749. doi: 10.1109/ojsp.2024.3378595. Epub 2024 Mar 18.
Bex T. Comprehensive Guide to Multiclass Classification With Sklearn. Towards Data Science. 2021.
Nicholas LE, Brookshire RH. A system for quantifying the informativeness and efficiency of the connected speech of adults with aphasia. J Speech Hear Res. 1993 Apr;36(2):338-50. doi: 10.1044/jshr.3602.338.
Buderer NM. Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med. 1996 Sep;3(9):895-900. doi: 10.1111/j.1553-2712.1996.tb03538.x.
Chen J, Ye J, Tang F, Zhou J. Automatic Detection of Alzheimer's Disease Using Spontaneous Speech Only. Interspeech. 2021 Aug-Sep;2021:3830-3834. doi: 10.21437/interspeech.2021-2002.
Agbavor F, Liang H. Predicting dementia from spontaneous speech using large language models. PLOS Digit Health. 2022 Dec 22;1(12):e0000168. doi: 10.1371/journal.pdig.0000168. eCollection 2022 Dec.
de la Fuente Garcia S, Ritchie CW, Luz S. Artificial Intelligence, Speech, and Language Processing Approaches to Monitoring Alzheimer's Disease: A Systematic Review. J Alzheimers Dis. 2020;78(4):1547-1574. doi: 10.3233/JAD-200888.
Other Identifiers
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SJ-1107
Identifier Type: -
Identifier Source: org_study_id
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