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

NCT07558785 | Enrolling By Invitation

• 1 other identifier: TQ01000332
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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)

  Through study completion, an average of 2 years

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

  Through study completion, an average of 2 years

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

  Through study completion, an average of 2 years

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

  Through study completion, an average of 2 years

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

  Through study completion, an average of 2 years

Study Arms (2)

Group of patients with neurocognitive disorder

EXPERIMENTAL

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)

Healthy elderly participants

ACTIVE COMPARATOR

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

the Mississippi Aphasia Screening Test DIAGNOSTIC_TEST

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

Group of patients with neurocognitive disorder; Healthy elderly participants

Amnesia Light and Brief Assessment (ALBA) DIAGNOSTIC_TEST

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

Group of patients with neurocognitive disorder; Healthy elderly participants

The Picture naming and immediate recall test (PICNIR) DIAGNOSTIC_TEST

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

Group of patients with neurocognitive disorder; Healthy elderly participants

Geriatric Depression Scale (GDS-15) DIAGNOSTIC_TEST

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.

Group of patients with neurocognitive disorder; Healthy elderly participants

The Beck Anxiety Inventory (BAI) DIAGNOSTIC_TEST

A formative assessment and rating scale of anxiety.

Group of patients with neurocognitive disorder; Healthy elderly participants

Digitial Diagnostics of Dementia (DDD) DIAGNOSTIC_TEST

Our experimental screening battery developed for this study.

Group of patients with neurocognitive disorder; Healthy elderly participants

The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) DIAGNOSTIC_TEST

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

Group of patients with neurocognitive disorder; Healthy elderly participants

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \- be diagnosed with mild neurocognitive impairment (MCI) or neurocognitive disorder (dementia) according to the international DSM-5 criteria

Sponsors & Collaborators

• Faculty Hospital Kralovske Vinohrady: lead

Study Sites (3)

Západočeská univerzita v Plzni / Fakulta aplikovaných věd

Pilsen, 306 14, Czechia

Location

Faculty Hospital Kralovske Vinohrady

Prague, 100 00, Czechia

Location

Fyzikální ústav AV ČR, v. v. i.

Prague, Czechia

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Luboš Šmídl, Ing. Ph.D.

  Západočeská univerzita v Plzni / Fakulta aplikovaných věd

  STUDY CHAIR

• Jan Švec, Ing. Ph.D.

  Západočeská univerzita v Plzni / Fakulta aplikovaných věd

  PRINCIPAL INVESTIGATOR

• Filip Polák, Ing.

  Západočeská univerzita v Plzni / Fakulta aplikovaných věd

  PRINCIPAL INVESTIGATOR

• Aleš Bartoš, prof. MUDr. Ph.D.

  Fakultní nemocnice Královské Vinohrady

  STUDY DIRECTOR

• Martin Víta, Mgr. Ph.D.

  Fyzikální ústav AV ČR, v. v. i.

  STUDY DIRECTOR

• Marie Kompasová, Mgr.

  Univerzita Karlova, Fakultní nemocnice Královské Vinohrady

  PRINCIPAL INVESTIGATOR

• Michaela Zapletalová, Mgr.

  Univerzita Palackého, Fakultní nemocnice Královské Vinohrady

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Marie Kompasova

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: April 30, 2026
• Study Start: September 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3)