Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models (AILAN)
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Petronilla Battista, PhD
- 電話番号:+390807814331
- メール:petronilla.battista@icsmaugeri.it
研究連絡先のバックアップ
- 名前:Gaia C Santi, PhD
- メール:gaia.santi@icsmaugeri.it
研究場所
-
-
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Bari、イタリア、70124
- 募集
- Istituti Clinici Scientifici Maugeri IRCCS Bari
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コンタクト:
- Petronilla Battista, PhD
- メール:petronilla.battista@icsmaugeri.it
-
コンタクト:
- Simona Aresta
- メール:simona.aresta@icsmaugeri.it
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副調査官:
- Gaia C Santi, PhD
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:非ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Performance of AI-based language analysis in distinguishing diagnostic groups
時間枠: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.)
|
協力者と研究者
捜査官
- 主任研究者:Petronilla Battista, PhD、Istituti Clinici Scientifici Maugeri IRCCS Bari
- スタディチェア:Gaia Santi, PhD、Istituti Clinici Scientifici Maugeri IRCCS Lumezzane
- スタディディレクター:Simona Aresta, PhD、Istituti Clinici Scientifici Maugeri IRCCS Bari
出版物と役立つリンク
一般刊行物
- Battista P, Salvatore C, Berlingeri M, Cerasa A, Castiglioni I. Artificial intelligence and neuropsychological measures: The case of Alzheimer's disease. Neurosci Biobehav Rev. 2020 Jul;114:211-228. doi: 10.1016/j.neubiorev.2020.04.026. Epub 2020 May 11.
- Palmirotta C, Aresta S, Battista P, Tagliente S, Lagravinese G, Mongelli D, Gelao C, Fiore P, Castiglioni I, Minafra B, Salvatore C. Unveiling the Diagnostic Potential of Linguistic Markers in Identifying Individuals with Parkinson's Disease through Artificial Intelligence: A Systematic Review. Brain Sci. 2024 Jan 28;14(2):137. doi: 10.3390/brainsci14020137.
- Battista, P., Aresta, S., Santacesaria, P., Benzini, A., Palmirotta, C., Tagliente, S., ... & Benussi, A. (2025). Natural Language Processing differentiates between Italian individuals with Nonfluent/Agrammatic from Logopenic variants of PPA. Alzheimer's & Dementia, 21, e105208.
- Aresta S, Battista P, Palmirotta C, Tagliente S, Lagravinese G, Santacesaria P, Benzini A, Mongelli D, Minafra B, Lunetta C, Garcia AM, Salvatore C. Digital phenotyping of Parkinson's disease via natural language processing. NPJ Parkinsons Dis. 2025 Jun 23;11(1):182. doi: 10.1038/s41531-025-01050-8.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Prot.2541/CEL
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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