Development of Deep Learning Models for Detection of Neurodegenerative Diseases Using Speech - a Danish Language-based Artificial Intelligence Study (DetectAI)
Trial ID: NCT07200739
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-06-01
Completion date: 2028-07
Sponsor: Zealand University Hospital
Collaborators: DemensAI ApS (private tech partner, Denmark)
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
Interventions: Mini-mental State Examination; Addenbrooke's Cognitive Examination; Speech Task - Picture Description; Speech Task - Picture Recall; MRI; blood sampling; Depression screening; Somatic- and neurological examination; Speech Task - Picture Narrative
Locations: Zealand University Hospital
Countries: Denmark
Enrollment: 440
Age range: 50 Years - None
Sex: ALL

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

Outcomes:
Model A: Primary measure is the AUC-ROC of the model in distinguishing between MCI and AD as well as between MCI and cognitively healthy control participants.