Mild Cognitive Impairment (MCI)NCT07558785
Telemedicine Self-examination of Speech and Memory for Rapid Detection of Cognitive Impairments Using Machine Learning Methods
A study testing The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Mississippi Aphasia Screening Test and Amnesia Light and Brief Assessment (ALBA) in people with Mild Cognitive Impairment (MCI) and Dementia, run by Faculty Hospital Kralovske Vinohrady at 3 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Dementia, Mild Cognitive Impairment (MCI) Amnestic
- What is being tested?
- The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Mississippi Aphasia Screening Test and Amnesia Light and Brief Assessment (ALBA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesCzechia
- Study dates
- 1 Sep 2023to 31 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia3 sites
Západočeská univerzita v Plzni / Fakulta aplikovaných věd
Pilsen, 306 14
Faculty Hospital Kralovske Vinohrady
Prague, 100 00
Fyzikální ústav AV ČR, v. v. i.
Prague
About this study
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)
- Being tested
- 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), Geriatric Depression Scale (GDS-15)
- Keywords
- digital diagnostics, cognition, Mild Cognitive Impairment (MCI), dementia, screening
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
the Mississippi Aphasia Screening TestDiagnostic test
he Mississippi Aphasia Screening Test (MAST) was developed as a brief, repeatable screening measure for individuals with severely impaired communication/language skills.
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).
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).
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.
The Beck Anxiety Inventory (BAI)Diagnostic test
A formative assessment and rating scale of anxiety.
Digitial Diagnostics of Dementia (DDD)Diagnostic test
Our experimental screening battery developed for this study.
| Study group | Role | What they receive |
|---|---|---|
| Group of patients with neurocognitive disorder | Experimental | The experimental group consists of patients with Mild Cognitive Impariment (MCI) and dementia. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Through study completion, an average of 2 years
Correlation of the results of our experimental battery (DDD) with RBANS
Measured: Through study completion, an average of 2 years
Correlation of the results of our experimental battery (DDD) with MAST
Measured: Through study completion, an average of 2 years
Correlation of the results of our experimental battery (DDD) with ALBA
Measured: Through study completion, an average of 2 years
Correlation of the results of our experimental battery (DDD) with POBAV
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Sep 2023
- Primary completion31 Dec 2025
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marie Kompasová, Faculty Hospital Kralovske Vinohrady
- Investigators
- Luboš Šmídl, Ing. Ph.D., Study chair, Západočeská univerzita v Plzni / Fakulta aplikovaných vědJan Švec, Ing. Ph.D., Principal investigator, Západočeská univerzita v Plzni / Fakulta aplikovaných vědFilip Polák, Ing., Principal investigator, Západočeská univerzita v Plzni / Fakulta aplikovaných vědAleš Bartoš, prof. MUDr. Ph.D., Study director, Fakultní nemocnice Královské VinohradyMartin Víta, Mgr. Ph.D., Study director, Fyzikální ústav AV ČR, v. v. i.Marie Kompasová, Mgr., Principal investigator, Univerzita Karlova, Fakultní nemocnice Královské VinohradyMichaela Zapletalová, Mgr., Principal investigator, Univerzita Palackého, Fakultní nemocnice Královské Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558785
- Sponsor's protocol ID
- TQ01000332
- Other IDs
- TQ01000332
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No