[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608375":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":71,"centralContacts":75,"locations":84,"responsibleParty":102,"collaborators":104,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":117,"minAge":118,"maxAge":10,"enrollmentInfo":119,"targetDuration":10,"studyType":122,"phases":10,"briefSummary":123,"conditions":124,"keywords":134,"overallStatus":149,"whyStopped":10,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Zealand University Hospital","OTHER",[8,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitively Healthy Control Participants for Model A",null,"We seek to enroll 40 age-matched cognitively healthy control participants for the training of model A.",[13,14,15,16,17,18,19,20,21],"Diagnostic Test: Mini-mental State Examination","Diagnostic Test: Addenbrooke's Cognitive Examination","Other: Speech Task - Picture Description","Other: Speech Task - Picture Recall","Diagnostic Test: MRI","Diagnostic Test: blood sampling","Diagnostic Test: Depression screening","Other: Somatic- and neurological examination","Other: Speech Task - Picture Narrative",{"label":23,"type":10,"description":24,"interventionNames":25},"Patient Participants for Model A","We seek to retrospectively enroll patients from the ZUH memory clinic with a diagnosis of either Alzheimer's Disease (AD, n=50) or MCI (n=50), made within 6 months prior to enrollment. These participants will be used for the training of model A.",[13,14,15,16,21],{"label":27,"type":10,"description":28,"interventionNames":29},"Patient Participants for Model B","We will prospectively recruit newly referred patients for the memory clinic at ZUH. Enrollment happens at first patient visit. At this time, diagnosis is not yet known, but assumed present.",[13,14,15,16,21],[31,38,43,47,51,55,59,63,67],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"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.",[9,23,27],[37],"MMSE",{"type":32,"name":39,"description":34,"armGroupLabels":40,"otherNames":41},"Addenbrooke's Cognitive Examination",[9,23,27],[42],"ACE",{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":10},"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.",[9,23,27],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":10},"Speech Task - Picture Recall","Participants will be asked to recall the picture shown in the previous speech task \"Picture Narrative\". This task will take 2 minutes. Participants will be recorded during the test in order til allow the AI to learn and analyze speech patterns.",[9,23,27],{"type":32,"name":52,"description":53,"armGroupLabels":54,"otherNames":10},"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).\n\nFor patient participants, imaging will be performed as part of the standard diagnostic battery and results will be obtained from the electronic journal.",[9],{"type":32,"name":56,"description":57,"armGroupLabels":58,"otherNames":10},"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.\n\nFor patient participants, blood sampling will be performed as part of the standard diagnostic battery and results will be obtained from the electronic journal.",[9],{"type":32,"name":60,"description":61,"armGroupLabels":62,"otherNames":10},"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 \\\u003C65 year of age.\n\nFor patient participants, depression screening will be performed as part of the standard diagnostic battery and results will be obtained from the electronic journal.",[9],{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":10},"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.\n\nFor patient participants, a somatic and neurological examination will be performed as part of the standard diagnostic battery and results will be obtained from the electronic journal",[9],{"type":6,"name":68,"description":69,"armGroupLabels":70,"otherNames":10},"Speech Task - Picture Narrative","The participant is asked to tell a brief story based on a culturally neutral picture. This task will take approximately 2 minutes. Participants will be recorded during the speech task in order to allow the AI to learn and analyze the speech patterns",[9,23,27],[72],{"name":73,"affiliation":5,"role":74},"Peter Høgh, MD, PhD, Assoc Prof","PRINCIPAL_INVESTIGATOR",[76,81],{"name":77,"role":78,"phone":79,"phoneExt":10,"email":80},"Sofie J Vængebjerg, MD","CONTACT","+4530294621","sova@regsj.dk",{"name":73,"role":78,"phone":82,"phoneExt":10,"email":83},"+45 22526698","phh@regionsjaelland.dk",[85],{"facility":5,"status":10,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Roskilde","Region Sjælland","4000","Denmark","DK",{"type":92,"coordinates":93},"Point",[94,95],12.08035,55.64152,{"lat":95,"lon":94},[98,101],{"name":99,"role":78,"phone":100,"phoneExt":10,"email":80},"Sofie J Vængebjerg, MD, PhD student","+45 30294621",{"name":73,"role":78,"phone":10,"phoneExt":10,"email":83},{"type":103,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[105],{"name":106,"class":107},"DemensAI ApS (private tech partner, Denmark)","UNKNOWN","100608375","speech-based-artificial-intelligence-for-detection-of-dementia-in-danish-patients-detectai-100608375",false,"NCT07200739","Speech-Based Artificial Intelligence for Detection of Dementia in Danish Patients (DetectAI)","Development of Deep Learning Models for Detection of Neurodegenerative Diseases Using Speech - a Danish Language-based Artificial Intelligence Study (DetectAI)","DetectAI","Inclusion Criteria:\n\nModel A (patient participants)\n\n* Age \\> 50 years\n* Fluent in Danish\n* Minimum of 7 years of schooling\n* A diagnosis of either MCI or AD, given at the SUH memory clinic within 6 months before enrollment\n\nModel A (cognitively healthy controls)\n\n* Age \\> 50 years\n* Fluent in Danish\n* Minimum of 7 years of schooling\n\nModel B:\n\n* Age \\> 50 years\n* Fluent in Danish\n* Minimum of 7 years of schooling\n\nExclusion Criteria:\n\nModel A:\n\nPatients:\n\n* Significantly impaired vision or hearing (to the extent that the patient cannot participate in the AI analysis)\n* MMSE score \\\u003C 16\n* Concomitant diagnoses which are expected to influence cognitive impairment (eg. depression)\n* Patients unable to give consent\n* Patients with alcohol consumption \\>21 standard alcohol units per week\n* Any history of speech or language impairment predating the current condition\n\nCognitively healthy controls:\n\n* Significantly impaired vision or hearing (to the extent that the patient cannot participate in the AI analysis)\n* MMSE \\\u003C 26 and ACE \\\u003C 90\n* Clinical, laboratory, or neuroradiological findings that could affect cognitive functions\n* Known diseases which are expected to impair cognitive functions\n* Any history of speech or language impairment predating the current condition\n* Patients with alcohol consumption \\>21 standard alcohol units per week.\n\nModel B:\n\n* Significantly impaired vision or hearing (to the extent that the patient cannot participate in the AI analysis)\n* MMSE score \\\u003C 16\n* Patients unable to give consent\n* Patients with concomitant psychosis or severe psychiatric comorbidities other than depression\n* Any history of speech or language impairment predating the current condition",true,"ALL","50 Years",{"count":120,"type":121},440,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn if an artificial intelligence (AI)-based speech analysis tool can identify which patients with memory problems need specialist evaluation at a memory clinic. The main questions it aims to answer are:\n\nCan the AI model accurately distinguish between patients who need referral to a memory clinic (those with dementia or Mild Cognitive Impairment) and patients who don't (those with normal cognition or memory problems from other causes like depression)? Which speech patterns and cognitive test features are most useful for making this distinction?\n\nResearchers will compare speech recordings and cognitive test results from patients diagnosed with dementia or MCI to those from patients with normal cognition or non-neurodegenerative cognitive impairment to see if the AI model can reliably predict who needs specialist dementia care.\n\nParticipants will:\n\nComplete standard cognitive tests at the memory clinic Perform structured speech tasks while being audio-recorded Receive their usual clinical evaluation and diagnosis from memory clinic specialists\n\nThe results of this study will help develop a tool that can assist doctors in making faster, more accurate decisions about which patients need specialist dementia evaluation, potentially leading to earlier diagnosis and better patient outcomes.",[125,126,127,128,129,130,131,132,133],"Dementia (Diagnosis)","Alzheimer Dementia (AD)","Vascular Dementia (VaD)","Lewy Body Dementia (LBD)","Frontotemporal Dementia (FTD)","Mild Cognitive Impairment (MCI)","Depression - Major Depressive Disorder","Stress","Cognitive Impairment",[135,136,137,138,139,140,141,142,143,128,129,130,144,145,146,147,133,148],"artificial intelligence","speech-based artificial intelligence","artificial intelligence in dementia diagnostics","artificial intelligence for dementia screening","artificial intelligence for dementia classification","speech based artificial intelligence","dementia","Vascular dementia (VaD)","Alzheimer dementia (AD)","Depression - Major Depressive disorder","Dementia (diagnosis)","machine learning","stress","deep learning","NOT_YET_RECRUITING","2026-04-28",{"date":152,"type":153},"2026-05-05","ACTUAL",{"date":155,"type":121},"2026-06-01",{"date":157,"type":121},"2028-07",{"name":5,"class":6},1]