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Not Yet Recruiting NCT07200739

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

Conditions: 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

Sex: All
Ages: 50 Years – N/A
Healthy volunteers: Yes
Enrollment: 440
Sponsor: Zealand University Hospital

Location: Zealand University Hospital Roskilde Region Sjælland

Summary

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: Can 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? Researchers 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. Participants will: Complete 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 The 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.

Eligibility Criteria

Inclusion Criteria: Model A (patient participants) * Age \> 50 years * Fluent in Danish * Minimum of 7 years of schooling * A diagnosis of either MCI or AD, given at the SUH memory clinic within 6 months before enrollment Model A (cognitively healthy controls) * Age \> 50 years * Fluent in Danish * Minimum of 7 years of schooling Model B: * Age \> 50 years * Fluent in Danish * Minimum of 7 years of schooling Exclusion Criteria: Model A: Patients: * Significantly impaired vision or hearing (to the extent that the patient cannot participate in the AI analysis) * MMSE score \< 16 * Concomitant diagnoses which are expected to influence cognitive impairment (eg. depression) * Patients unable to give consent * Patients with alcohol consumption \>21 standard alcohol units per week * Any history of speech or language impairment predating the current condition Cognitively healthy controls: * Significantly impaired vision or hearing (to the extent that the patient cannot participate in the AI analysis) * MMSE \< 26 and ACE \< 90 * Clinical, laboratory, or neuroradiological findings that could affect cognitive functions * Known diseases which are expected to impair cognitive functions * Any history of speech or language impairment predating the current condition * Patients with alcohol consumption \>21 standard alcohol units per week. Model B: * Significantly impaired vision or hearing (to the extent that the patient cannot participate in the AI analysis) * MMSE score \< 16 * Patients unable to give consent * Patients with concomitant psychosis or severe psychiatric comorbidities other than depression * Any history of speech or language impairment predating the current condition

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07200739). StuddyBuddy aggregates publicly available trial information.