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

2 de noviembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Performance of AI-based language analysis in distinguishing diagnostic groups
Periodo de tiempo: 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.)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Petronilla Battista, PhD, Istituti Clinici Scientifici Maugeri IRCCS Bari
  • Silla de estudio: Gaia Santi, PhD, Istituti Clinici Scientifici Maugeri IRCCS Lumezzane
  • Director de estudio: Simona Aresta, PhD, Istituti Clinici Scientifici Maugeri IRCCS Bari

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de octubre de 2025

Finalización primaria (Estimado)

31 de enero de 2028

Finalización del estudio (Estimado)

31 de octubre de 2028

Fechas de registro del estudio

Enviado por primera vez

26 de octubre de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de octubre de 2026

Publicado por primera vez (Actual)

30 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Prot.2541/CEL

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .