An interventional study of Speech and language Test to support clinical diagnosis in Alzheimer's Disease (AD), Frontotemporal Dementia (FTD) and Parkinsons Disease (PD), sponsored by Istituti Clinici Scientifici Maugeri SpA. Recruiting at 1 site in Italy. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Istituti Clinici Scientifici Maugeri SpA · Not applicable, Interventional, and Diagnostic
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.
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 200 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 126 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants with neurodegenerative diseases
Inclusion criteria
Exclusion criteria
Healthy controls
Inclusion criteria
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy control participants will complete a one-time remote speech and language assessment. No therapeutic intervention will be administered.
Behavioral: Speech and language Test to support clinical diagnosis
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.
Behavioral: Speech and language Test to support clinical diagnosis
Participants with frontotemporal dementia will complete a one-time remote speech and language assessment. No therapeutic intervention will be administered.
Behavioral: Speech and language Test to support clinical diagnosis
Participants with Alzheimer's disease will complete a one-time remote speech and language assessment. No therapeutic intervention will be administered.
Behavioral: Speech and language Test to support clinical diagnosis
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.
Performance of AI-based language analysis in distinguishing diagnostic groups
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.
Time frame: Day 1 (At completion of the one-time remote speech and language assessment and analysis.)
Plan to share: No — 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.
Started Oct 2025 (actual). Primary completion is estimated for Jan 2028, 27 months after the start.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 27 months is close to that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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