Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models (AILAN)

2 november 2026 bijgewerkt door: Istituti Clinici Scientifici Maugeri SpA

Analisi Automatizzata Del Linguaggio Nelle Malattie Neurodegenerative: Applicazione di Modelli di Intelligenza Artificiale

This multicenter study aims to characterize the language profiles of patients with various neurodegenerative diseases, including Alzheimer's disease (AD), Primary Progressive Aphasia (PPA), behavioral variant Frontotemporal Dementia (bvFTD), Dementia with Lewy Bodies (DLB), and Parkinson's disease (PD), using artificial intelligence (AI) models. By analyzing speech and language data collected during remote neuropsychological assessments, the researchers intend to identify objective linguistic biomarkers suitable for early and differential diagnosis, overcoming the limitations of traditional, invasive, and costly diagnostic tools. The project will develop and validate an AI-driven pipeline to provide scalable and individualized linguistic profiles, ultimately supporting personalized treatment strategies and improving clinical workflow efficiency in the Italian population.

Studie Overzicht

Gedetailleerde beschrijving

Neurodegenerative disorders pose significant diagnostic challenges, particularly in differentiating conditions with overlapping clinical symptoms and neuroanatomy. Although language impairment is a hallmark symptom across several forms of dementia, existing diagnostic tools are often costly, time-consuming, and lack cultural sensitivity, particularly for the Italian language. Artificial Intelligence (AI) offers a promising, non-invasive approach to extracting objective acoustic, prosodic, and linguistic markers from speech data.

The primary objective of this study is to characterize the language profiles of patients diagnosed with AD, PPA, bvFTD, DLB, and PD compared to healthy controls (HC). Specific objectives include: 1) Identifying distinct linguistic and speech features that act as surrogate biomarkers for early and differential diagnosis; 2) Using machine learning to optimize classification algorithms; and 3) Implementing Explainable AI (XAI) to ensure the interpretability of diagnostic outputs, thereby facilitating clinical trust and adoption of AI-driven tools in the diagnostic process.

This is a prospective, experimental, multicenter study. A total of 168 participants (24 per group: AD, PPA, bvFTD, DLB, PD, and HC) will be enrolled. Participants will undergo a 1.5-hour remote neuropsychological and logopedic evaluation via a secure, HIPAA-compliant videoconferencing platform. The assessment includes spontaneous speech tasks (e.g., image descriptions) and standardized language and cognitive tests. Audio data will be recorded and processed using an AI pipeline, including automatic speech recognition for transcription and various Natural Language Processing (NLP) techniques-such as BERT, RoBERTa, and UmBERTo-to extract complex linguistic and semantic features.

Data analysis will involve training machine learning classifiers (e.g., Support Vector Machines, Random Forests) to distinguish between diagnostic groups, utilizing nested cross-validation to ensure robustness. XAI techniques, including SHAP (Shapley Additive Explanations) and LIME (Local Interpretable Model-agnostic Explanations), will be applied to enhance the transparency of the model's decisions, allowing clinicians to interpret the pathological language patterns driving the classification. The study aims to establish the first structured Italian corpus for the linguistic characterization of neurodegenerative disorders, providing a foundation for future cross-linguistic analysis.

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 90 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Participants with neurodegenerative diseases

Inclusion criteria

  • Diagnosis of mild cognitive impairment due to Alzheimer's disease (AD), primary progressive aphasia (PPA), behavioral variant frontotemporal dementia (bvFTD), dementia with Lewy bodies (DLB), or Parkinson's disease (PD).
  • Age 40-85 years.
  • Italian native speaker.
  • Able to provide informed consent.

Exclusion criteria

  • Mini-Mental State Examination (MMSE) score below 15.
  • Other neurological or psychiatric diagnoses, including cerebrovascular disease documented by MRI or CT.
  • Severe, uncorrected hearing or visual impairment.
  • Clinical Dementia Rating (CDR) score above 1.

Healthy controls

Inclusion criteria

  • Italian native speaker.
  • Matched to the patient groups for age, sex, and education level.

Exclusion criteria

  • History of systemic, neurological, or psychiatric disease.
  • Substance abuse.
  • Family history of neurodegenerative disease.
  • MMSE score below 27/30.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Healthy Controls

Healthy control participants will complete a one-time remote speech and language assessment. No therapeutic intervention will be administered.

Participants will complete a one-time remote speech and language assessment. Speech and language samples will be collected and analyzed using artificial intelligence and machine-learning methods. No therapeutic intervention will be administered.

Experimenteel: Lewy bodies or Parkinson's

Participants with dementia with Lewy bodies or Parkinson's disease will complete a one-time remote speech and language assessment. No therapeutic intervention will be administered.

Participants will complete a one-time remote speech and language assessment. Speech and language samples will be collected and analyzed using artificial intelligence and machine-learning methods. No therapeutic intervention will be administered.

Experimenteel: frontotemporal dementia

Participants with frontotemporal dementia will complete a one-time remote speech and language assessment. No therapeutic intervention will be administered.

Participants will complete a one-time remote speech and language assessment. Speech and language samples will be collected and analyzed using artificial intelligence and machine-learning methods. No therapeutic intervention will be administered.

Experimenteel: Alzheimer's Disease (AD)

Participants with Alzheimer's disease will complete a one-time remote speech and language assessment. No therapeutic intervention will be administered.

Participants will complete a one-time remote speech and language assessment. Speech and language samples will be collected and analyzed using artificial intelligence and machine-learning methods. No therapeutic intervention will be administered.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Performance of AI-based language analysis in distinguishing diagnostic groups
Tijdsspanne: Day 1 (At completion of the one-time remote speech and language assessment and analysis.)

Accuracy of machine-learning models in classifying participants into the study groups (Alzheimer's disease, primary progressive aphasia, behavioral variant frontotemporal dementia, dementia with Lewy bodies, Parkinson's disease, and healthy controls) based on speech and language features from the remote assessment.

Day 1 (At completion of the one-time remote speech and language assessment and analysis.)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Petronilla Battista, PhD, Istituti Clinici Scientifici Maugeri IRCCS Bari
  • Studie stoel: Gaia Santi, PhD, Istituti Clinici Scientifici Maugeri IRCCS Lumezzane
  • Studie directeur: Simona Aresta, PhD, Istituti Clinici Scientifici Maugeri IRCCS Bari

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 oktober 2025

Primaire voltooiing (Geschat)

31 januari 2028

Studie voltooiing (Geschat)

31 oktober 2028

Studieregistratiedata

Eerst ingediend

26 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 oktober 2026

Eerst geplaatst (Werkelijk)

30 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared because the speech and language recordings and related clinical information are sensitive and potentially identifiable. The study team will protect participant confidentiality and use the data only for the purposes described in the protocol.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren