ClinicalTrials.gg
Enrolling by invitationNCT07558785Updated Apr 30, 2026

Telemedicine Self-examination of Speech and Memory for Rapid Detection of Cognitive Impairments Using Machine Learning Methods

An interventional study of The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Mississippi Aphasia Screening Test in Mild Cognitive Impairment (MCI), Dementia and Mild Cognitive Impairment (MCI) Amnestic, sponsored by Faculty Hospital Kralovske Vinohrady. Enrolling by invitation at 3 sites in Czechia. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Faculty Hospital Kralovske Vinohrady · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Sep 2023, registered Dec 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Non-randomized
Ages
40 Years and older
Sex
All
01

Study summary

Early cognitive disorders diagnosis is becoming increasingly important due to population aging. The most common causes include Alzheimer's disease and frontotemporal dementia. These diseases are also manifested by changes in speech. NLP allows us to identify and classify these changes. The project aims to develop a web application for self-assessment and automated detection of cognitive disorders from speech. The application will have a form of a dialogue system using machine learning methods. The novelty of this approach is the possibility of an efficient self-assessment of a wide spectrum of the Czech population from their homes and an automated evaluation of test results. Early detection can be followed by a more detailed diagnosis and adequate treatment.

02

Conditions studied

  • Mild Cognitive Impairment (MCI)
  • Dementia
  • Mild Cognitive Impairment (MCI) Amnestic
  • Frontotemporal Degeneration (FTD)
  • Alzheimer Disease (AD)

Keywords

  • digital diagnostics
  • cognition
  • Mild Cognitive Impairment (MCI)
  • dementia
  • screening
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 500 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Faculty Hospital Kralovske Vinohrady is the lead sponsor of 30 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria for the group of healthy participants:

  • age over 45 years
  • Czech as the native language
  • must meet the criteria in a questionnaire with questions focused on a history of brain injury or psychiatric history or medication use
  • must achieve normal scores on questionnaires assessing mood

Inclusion Criteria for the group of patients:

- be diagnosed with mild neurocognitive impairment (MCI) or neurocognitive disorder (dementia) according to the international criteria

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Group of patients with neurocognitive disorder

    The experimental group consists of patients with Mild Cognitive Impariment (MCI) and dementia.

    Diagnostic Test: The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) · Diagnostic Test: the Mississippi Aphasia Screening Test · Diagnostic Test: Amnesia Light and Brief Assessment (ALBA) · Diagnostic Test: The Picture naming and immediate recall test (PICNIR) · Diagnostic Test: Geriatric Depression Scale (GDS-15) · Diagnostic Test: The Beck Anxiety Inventory (BAI) · Diagnostic Test: Digitial Diagnostics of Dementia (DDD)

  • Active comparator
    Healthy elderly participants

    The control group consists of cognitively healthy elderly participants.

    Diagnostic Test: The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) · Diagnostic Test: the Mississippi Aphasia Screening Test · Diagnostic Test: Amnesia Light and Brief Assessment (ALBA) · Diagnostic Test: The Picture naming and immediate recall test (PICNIR) · Diagnostic Test: Geriatric Depression Scale (GDS-15) · Diagnostic Test: The Beck Anxiety Inventory (BAI) · Diagnostic Test: Digitial Diagnostics of Dementia (DDD)

Interventions

  • Diagnostic testThe Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    A brief individually administered battery to measure cognitive decline or improvement across five domains in ages 12 to 89 years 11 months.

  • Diagnostic testthe Mississippi Aphasia Screening Test

    he Mississippi Aphasia Screening Test (MAST) was developed as a brief, repeatable screening measure for individuals with severely impaired communication/language skills.

  • Diagnostic testAmnesia Light and Brief Assessment (ALBA)

    Very brief test used to measure deficits of more cognitive functions (short-term, episodic, semantic amnesia, sensory and motor aphasia, apraxia, psychomotor speed).

  • Diagnostic testThe Picture naming and immediate recall test (PICNIR)

    Very brief test used to measure deficits of more cognitive functions (short-term, episodic, semantic amnesia, sensory and motor aphasia, apraxia, psychomotor speed).

  • Diagnostic testGeriatric Depression Scale (GDS-15)

    The Geriatric Depression Scale (GDS-15), used to screen for depression in adults aged 55 and older, consists of 15 items that assess mental health based on feelings over the past week.

  • Diagnostic testThe Beck Anxiety Inventory (BAI)

    A formative assessment and rating scale of anxiety.

  • Diagnostic testDigitial Diagnostics of Dementia (DDD)

    Our experimental screening battery developed for this study.

06

What researchers measure

Primary outcomes

  1. The difference in results between groups of patients with cognitive impairment and healthy individuals in individual parts of our experimental neuropsychological battery Diagnostic Test: Digitial Diagnostics of Dementia (DDD)

    Time frame: Through study completion, an average of 2 years

  2. Correlation of the results of our experimental battery (DDD) with RBANS

    Time frame: Through study completion, an average of 2 years

  3. Correlation of the results of our experimental battery (DDD) with MAST

    Time frame: Through study completion, an average of 2 years

  4. Correlation of the results of our experimental battery (DDD) with ALBA

    Time frame: Through study completion, an average of 2 years

  5. Correlation of the results of our experimental battery (DDD) with POBAV

    Time frame: Through study completion, an average of 2 years

07

Study locations

3 sites
  • Západočeská univerzita v Plzni / Fakulta aplikovaných věd
    Pilsen, 306 14, Czechia
  • Faculty Hospital Kralovske Vinohrady
    Prague, 100 00, Czechia
  • Fyzikální ústav AV ČR, v. v. i.
    Prague, Czechia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07558785
Lead sponsor
Faculty Hospital Kralovske Vinohrady
Responsible party
Marie Kompasová (Principal Investigator Marie Kompasova, Faculty Hospital Kralovske Vinohrady) — Principal investigator
First posted
Apr 30, 2026
Start date
Sep 1, 2023
Primary completion
Dec 31, 2025
Completion
Aug 31, 2026 (estimated)
Last update
Apr 30, 2026

Study contacts

Luboš Šmídl, Ing. Ph.D.
study chair · Západočeská univerzita v Plzni / Fakulta aplikovaných věd
Jan Švec, Ing. Ph.D.
principal investigator · Západočeská univerzita v Plzni / Fakulta aplikovaných věd
Filip Polák, Ing.
principal investigator · Západočeská univerzita v Plzni / Fakulta aplikovaných věd
Aleš Bartoš, prof. MUDr. Ph.D.
study director · Fakultní nemocnice Královské Vinohrady
Martin Víta, Mgr. Ph.D.
study director · Fyzikální ústav AV ČR, v. v. i.
Marie Kompasová, Mgr.
principal investigator · Univerzita Karlova, Fakultní nemocnice Královské Vinohrady
Michaela Zapletalová, Mgr.
principal investigator · Univerzita Palackého, Fakultní nemocnice Královské Vinohrady

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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