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Enrolling by invitation NCT07558785

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

No phase Interventional Mild Cognitive Impairment (MCI) Dementia Mild Cognitive Impairment (MCI) Amnestic Frontotemporal Degeneration (FTD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Mississippi Aphasia Screening Test, Amnesia Light and Brief Assessment (ALBA), The Picture naming and immediate recall test (PICNIR).
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI), Dementia, Mild Cognitive Impairment (MCI) Amnestic, Frontotemporal Degeneration (FTD). Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Diagnostic test The 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 test the 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 test Amnesia 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 test The 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 test Geriatric 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 test The Beck Anxiety Inventory (BAI)
    A formative assessment and rating scale of anxiety.
  • Diagnostic test Digitial Diagnostics of Dementia (DDD)
    Our experimental screening battery developed for this study.

Primary outcome measures

  • 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]
  • Correlation of the results of our experimental battery (DDD) with RBANS [Time frame: Through study completion, an average of 2 years]
  • Correlation of the results of our experimental battery (DDD) with MAST [Time frame: Through study completion, an average of 2 years]
  • Correlation of the results of our experimental battery (DDD) with ALBA [Time frame: Through study completion, an average of 2 years]
  • Correlation of the results of our experimental battery (DDD) with POBAV [Time frame: Through study completion, an average of 2 years]

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 DSM-5 criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Czechia · 3 centers
  • Západočeská univerzita v Plzni / Fakulta aplikovaných věd — Pilsen
  • Faculty Hospital Kralovske Vinohrady — Prague
  • Fyzikální ústav AV ČR, v. v. i. — Prague

Identifiers

NCT: NCT07558785 · TQ01000332 · TQ01000332

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗