NCT07200739 · NOT YET RECRUITING

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

This observational study tests whether an AI tool can analyze recorded speech to help spot which people with memory complaints need a specialist memory clinic evaluation. Participants describe pictures aloud and take standard memory tests. Nothing is given or treated. No phase applies, since this is a diagnostic tool study in Denmark, not a drug trial.

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

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-09-02

View full record on ClinicalTrials.gov

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