- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07558785
Telemedicine Self-examination of Speech and Memory for Rapid Detection of Cognitive Impairments Using Machine Learning Methods
27. april 2026 oppdatert av: Marie Kompasová, Faculty Hospital Kralovske Vinohrady
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.
Studieoversikt
Status
Påmelding etter invitasjon
Forhold
Intervensjon / Behandling
- Diagnostisk test: The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- Diagnostisk test: the Mississippi Aphasia Screening Test
- Diagnostisk test: Amnesia Light and Brief Assessment (ALBA)
- Diagnostisk test: The Picture naming and immediate recall test (PICNIR)
- Diagnostisk test: Geriatric Depression Scale (GDS-15)
- Diagnostisk test: The Beck Anxiety Inventory (BAI)
- Diagnostisk test: Digitial Diagnostics of Dementia (DDD)
Studietype
Intervensjonell
Registrering (Antatt)
500
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pilsen, Tsjekkia, 306 14
- Západočeská univerzita v Plzni / Fakulta aplikovaných věd
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Prague, Tsjekkia, 100 00
- Faculty Hospital Kralovske Vinohrady
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Prague, Tsjekkia
- Fyzikální ústav AV ČR, v. v. i.
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Group of patients with neurocognitive disorder
The experimental group consists of patients with Mild Cognitive Impariment (MCI) and dementia.
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A brief individually administered battery to measure cognitive decline or improvement across five domains in ages 12 to 89 years 11 months.
he Mississippi Aphasia Screening Test (MAST) was developed as a brief, repeatable screening measure for individuals with severely impaired communication/language skills.
Very brief test used to measure deficits of more cognitive functions (short-term, episodic, semantic amnesia, sensory and motor aphasia, apraxia, psychomotor speed).
Very brief test used to measure deficits of more cognitive functions (short-term, episodic, semantic amnesia, sensory and motor aphasia, apraxia, psychomotor speed).
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.
A formative assessment and rating scale of anxiety.
Our experimental screening battery developed for this study.
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Aktiv komparator: Healthy elderly participants
The control group consists of cognitively healthy elderly participants.
|
A brief individually administered battery to measure cognitive decline or improvement across five domains in ages 12 to 89 years 11 months.
he Mississippi Aphasia Screening Test (MAST) was developed as a brief, repeatable screening measure for individuals with severely impaired communication/language skills.
Very brief test used to measure deficits of more cognitive functions (short-term, episodic, semantic amnesia, sensory and motor aphasia, apraxia, psychomotor speed).
Very brief test used to measure deficits of more cognitive functions (short-term, episodic, semantic amnesia, sensory and motor aphasia, apraxia, psychomotor speed).
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.
A formative assessment and rating scale of anxiety.
Our experimental screening battery developed for this study.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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)
Tidsramme: Through study completion, an average of 2 years
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Through study completion, an average of 2 years
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Correlation of the results of our experimental battery (DDD) with RBANS
Tidsramme: Through study completion, an average of 2 years
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Through study completion, an average of 2 years
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Correlation of the results of our experimental battery (DDD) with MAST
Tidsramme: Through study completion, an average of 2 years
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Through study completion, an average of 2 years
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Correlation of the results of our experimental battery (DDD) with ALBA
Tidsramme: Through study completion, an average of 2 years
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Through study completion, an average of 2 years
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Correlation of the results of our experimental battery (DDD) with POBAV
Tidsramme: Through study completion, an average of 2 years
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Through study completion, an average of 2 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Luboš Šmídl, Ing. Ph.D., Západočeská univerzita v Plzni / Fakulta aplikovaných věd
- Hovedetterforsker: Jan Švec, Ing. Ph.D., Západočeská univerzita v Plzni / Fakulta aplikovaných věd
- Hovedetterforsker: Filip Polák, Ing., Západočeská univerzita v Plzni / Fakulta aplikovaných věd
- Studieleder: Aleš Bartoš, prof. MUDr. Ph.D., Fakultni nemocnice Kralovske Vinohrady
- Studieleder: Martin Víta, Mgr. Ph.D., Fyzikální ústav AV ČR, v. v. i.
- Hovedetterforsker: Marie Kompasová, Mgr., Univerzita Karlova, Fakultní nemocnice Královské Vinohrady
- Hovedetterforsker: Michaela Zapletalová, Mgr., Univerzita Palackého, Fakultní nemocnice Královské Vinohrady
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. september 2023
Primær fullføring (Faktiske)
31. desember 2025
Studiet fullført (Antatt)
31. august 2026
Datoer for studieregistrering
Først innsendt
16. desember 2025
Først innsendt som oppfylte QC-kriteriene
27. april 2026
Først lagt ut (Faktiske)
30. april 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. april 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TQ01000332 (Annet stipend/finansieringsnummer: Technology Agency of the Czech Republic)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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Nei
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