Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME) (I-FACE)
Sviluppo, Validazione e Dati Normativi Della Batteria Italiana Per il Riconoscimento Dei Volti Famosi I-FACE
The I-FACE project aims to develop and validate a battery to assess famous-face recognition in people with neurodegenerative diseases and stroke. It will examine face naming, familiarity, and semantic knowledge, establish norms for the Italian population, and test how well the measures identify recognition difficulties in patients with frontotemporal dementia, Alzheimer's disease, and stroke.
調査の概要
状態
詳細な説明
The I-FACE project aims to develop and clinically validate a comprehensive neuropsychological battery for assessing famous-face recognition in people with neurodegenerative diseases and in stroke survivors. Face-recognition difficulties can affect a person's ability to identify familiar individuals and access information about them, yet these abilities are not always assessed systematically in clinical practice.
The battery will examine three components of famous-face recognition: Familiarity, or knowing that a face has been seen before; semantic knowledge, or retrieving information such as the person's profession; and naming, or producing the person's name. It will include four tasks: Famous Faces Confrontation Naming (FFCN), Famous Faces Semantic Association based on profession (FFSA), Famous Faces Triplet Words (FFTW), which assesses semantic associations using written names, and the Famous Faces Familiarity Judgement Task (FFFJT).
A pilot study will be used to refine the tasks and select items with good internal consistency. The researchers will then collect normative data from Italian participants, considering age, sex, and educational level, and establish cut-off scores for each subtest. Finally, the battery will be administered to people with frontotemporal dementia, Alzheimer's disease, and stroke to assess its reliability and validity. Its ability to distinguish patients with face-recognition impairments from healthy individuals will be evaluated using measures including sensitivity, specificity, and ROC curve analyses. The overall aim is to provide a reliable tool for identifying and characterizing these difficulties, including subtle deficits that may support earlier and more accurate clinical assessment.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Petronilla Battista, PhD
- 電話番号：+39 0807814331
- メール：petronilla.battista@icsmaugeri.it
研究連絡先のバックアップ
- 名前：Serena Tagliente, MSc
- 電話番号：+39 0807814331
- メール：serena.tagliente@icsmaugeri.it
研究場所
-
-
-
Bari、イタリア、70124
- 募集
- Istituti Clinici Scientifici Maugeri IRCCS Bari
-
コンタクト：
- Stefania De Trane, MD
- メール：stefania.detrane@icsmaugeri.it
-
コンタクト：
- Serena Tagliente, MSc
- 電話番号：+390807814331
- メール：serena.tagliente@icsmaugeri.it
-
Milan、イタリア、20138
- 募集
- Istituti Clinici Scientifici Maugeri IRCCS Milano
-
コンタクト：
- Christian Lunetta, MD
- 電話番号：+39 02 5072 5266
- メール：christian.lunetta@icsmaugeri.it
-
コンタクト：
- Claudia Bossi, MSc
- 電話番号：+39 0382 592048
- メール：claudia.bossi@icsmaugeri.it
-
副調査官：
- Debora Pain, MSc
-
Pavia、イタリア、27100
- 募集
- IRCCS Maugeri Pavia
-
コンタクト：
- Marina Manera, MSc
- 電話番号：0382 592952
- メール：marina.manera@icsmaugeri.it
-
Telese Terme、イタリア、82037
- 募集
- IRCCS Maugeri Telese Terme
-
コンタクト：
- Pasquale Moretta, MSc
- 電話番号：+39 0824 909111
- メール：pasquale.moretta@icsmaugeri.it
-
Veruno、イタリア、28013
- まだ募集していません
- IRCCS Maugeri Veruno
-
コンタクト：
- Giusy Figliano, PhD
- 電話番号：0322 884711
- メール：giusi.figliano@icsmaugeri.it
-
-
AG
-
Sciacca、AG、イタリア、92019
- 募集
- ICS Maugeri Sciacca
-
コンタクト：
- Stefania Ruvolo, MSc
- メール：stefania.ruvolo@icsmaugeri.it
-
-
BS
-
Lumezzane、BS、イタリア、25065
- 募集
- IRCCS Maugeri Lumezzane
-
コンタクト：
- Lidia Gazzi, MSc
- 電話番号：+39 030 825 3011
- メール：lidia.gazzi@icsmaugeri.it
-
コンタクト：
- Gaia C Santi, PhD
- 電話番号：+39 030 825 3011
- メール：gaia.santi@icsmaugeri.it
-
-
ME
-
Mistretta、ME、イタリア、98073
- 募集
- ICS Maugeri Mistretta
-
コンタクト：
- Luisa Scaduto, MSc
- 電話番号：0921 389111
- メール：luisa.scaduto@icsmaugeri.it
-
-
MN
-
Castel Goffredo、MN、イタリア、46042
- まだ募集していません
- IRCCS Maugeri Castel Goffredo
-
コンタクト：
- Giuliana Vezzadini, MD
- メール：giuliana.vezzadini@icsmaugeri.it
-
-
PV
-
Montescano、PV、イタリア、27040
- 募集
- IRCCS Maugeri Montescano
-
コンタクト：
- Antonia Pierobon, MSc
- 電話番号：0385 2471
- メール：antonia.pierobon@icsmaugeri.it
-
-
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
サンプリング方法
調査対象母集団
The study will include adults aged 40-85 years in four groups: healthy controls, participants with probable frontotemporal dementia (FTD), participants with probable Alzheimer's disease (AD), and participants assessed in the subacute phase after stroke (1 week to 3 months after the event). Stroke must be ischemic or hemorrhagic and confirmed by neuroimaging and/or clinical assessment. Participants will be recruited from the study's clinical setting and assessed using the I-FACE neuropsychological battery. Group-specific eligibility criteria will be applied.
説明
-
Healthy Controls (HC)
Inclusion Criteria:
Age 40-85 years. No chronic medical, neurological, or psychiatric conditions, or major depressive episode detected during screening.
No history of schizophrenia or bipolar disorder in the 5 years prior to screening.
Mini-Mental State Examination (MMSE) score ≥ 26.
Exclusion Criteria:
Uncorrected vision or hearing impairment.
-
Frontotemporal Dementia (FTD) Patients
Inclusion Criteria:
Diagnosis of probable FTD according to established clinical criteria. Age 40-85 years. Ability to provide informed consent.
Exclusion Criteria:
History of neurological diseases other than FTD (e.g., stroke, brain tumor, multiple sclerosis, traumatic brain injury).
Uncorrected vision or hearing impairment. History of serious psychiatric diseases, developmental disorders (e.g., autism spectrum), or intellectual disability.
Dementia severity (CDR) > 1.
-
Alzheimer's Disease (AD) Patients
Inclusion Criteria:
Diagnosis of probable AD according to established clinical criteria. Age 40-85 years. Ability to provide informed consent.
Exclusion Criteria:
History of neurological diseases other than AD (e.g., stroke, brain tumor, multiple sclerosis, traumatic brain injury).
Uncorrected vision or hearing impairment. History of serious psychiatric diseases, developmental disorders, or intellectual disability.
Dementia severity (CDR) > 1.
-
Post-Stroke Patients
Inclusion Criteria:
Subacute phase: 1 week to 3 months post-event. Ischemic or hemorrhagic stroke confirmed by neuroimaging and/or clinical judgment.
Exclusion Criteria:
History of previous stroke or multifocal stroke documented by imaging. Brainstem or cerebellar stroke. History of traumatic brain injury (TBI), seizures, brain tumors, neurodegenerative diseases, or psychiatric disorders.
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Healthy controls
Control participants will be administered the experimental neuropsychological battery to establish normative data. |
Participants will complete the I-FACE neuropsychological assessment battery as outlined in the study protocol. The assessment includes standardised cognitive tests and questionnaires to evaluate the relevant cognitive domains. Participants will complete it once, and it does not involve therapeutic treatment or an investigational drug. |
|
Patients with Alzheimer's disease
Patients with AD will be administered the experimental neuropsychological battery to establish the clinical validity of the FAME |
Participants will complete the I-FACE neuropsychological assessment battery as outlined in the study protocol. The assessment includes standardised cognitive tests and questionnaires to evaluate the relevant cognitive domains. Participants will complete it once, and it does not involve therapeutic treatment or an investigational drug. |
|
Patients with Frontotemporal dementia
Patients with FTD will be administered the experimental neuropsychological battery to establish the clinical validity of the FAME |
Participants will complete the I-FACE neuropsychological assessment battery as outlined in the study protocol. The assessment includes standardised cognitive tests and questionnaires to evaluate the relevant cognitive domains. Participants will complete it once, and it does not involve therapeutic treatment or an investigational drug. |
|
Post-stroke survivors
Post-stroke survivors will be administered the experimental neuropsychological battery to establish the clinical validity of the FAME |
Participants will complete the I-FACE neuropsychological assessment battery as outlined in the study protocol. The assessment includes standardised cognitive tests and questionnaires to evaluate the relevant cognitive domains. Participants will complete it once, and it does not involve therapeutic treatment or an investigational drug. |
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 |
|---|---|---|
|
I-FACE total and subtest scores
時間枠：From enrollment to the end of neuropsychologic assessment (Day 1)
|
Participant performance on the four I-FACE tasks assessing famous-face naming, semantic association from faces, familiarity judgment, and semantic association from written names. Each item is scored 0 (incorrect/not identified) or 1 (correctly identified); total scores are calculated for each subtest. |
From enrollment to the end of neuropsychologic assessment (Day 1)
|
協力者と研究者
捜査官
- 主任研究者：Petronilla Battista, PhD、Istituti Clinici Scientifici Maugeri IRCCS
出版物と役立つリンク
一般刊行物
- Gorno-Tempini ML, Price CJ. Identification of famous faces and buildings: a functional neuroimaging study of semantically unique items. Brain. 2001 Oct;124(Pt 10):2087-97. doi: 10.1093/brain/124.10.2087.
- Gainotti G. Is the difference between right and left ATLs due to the distinction between general and social cognition or between verbal and non-verbal representations? Neurosci Biobehav Rev. 2015 Apr;51:296-312. doi: 10.1016/j.neubiorev.2015.02.004. Epub 2015 Feb 16.
- Chan D, Anderson V, Pijnenburg Y, Whitwell J, Barnes J, Scahill R, Stevens JM, Barkhof F, Scheltens P, Rossor MN, Fox NC. The clinical profile of right temporal lobe atrophy. Brain. 2009 May;132(Pt 5):1287-98. doi: 10.1093/brain/awp037. Epub 2009 Mar 18.
- Bruce V, Young A. Understanding face recognition. Br J Psychol. 1986 Aug;77 ( Pt 3):305-27. doi: 10.1111/j.2044-8295.1986.tb02199.x.
- Brambati SM, Benoit S, Monetta L, Belleville S, Joubert S. The role of the left anterior temporal lobe in the semantic processing of famous faces. Neuroimage. 2010 Nov 1;53(2):674-81. doi: 10.1016/j.neuroimage.2010.06.045. Epub 2010 Jun 30.
- Blank H, Wieland N, von Kriegstein K. Person recognition and the brain: merging evidence from patients and healthy individuals. Neurosci Biobehav Rev. 2014 Nov;47:717-34. doi: 10.1016/j.neubiorev.2014.10.022.
- Bizzozero I, Lucchelli F, Saetti MC, Spinnler H. "Whose face is this?": Italian norms of naming celebrities. Neurol Sci. 2007 Dec;28(6):315-22. doi: 10.1007/s10072-007-0845-6. Epub 2008 Jan 4.
- Binney RJ, Henry ML, Babiak M, Pressman PS, Santos-Santos MA, Narvid J, Mandelli ML, Strain PJ, Miller BL, Rankin KP, Rosen HJ, Gorno-Tempini ML. Reading words and other people: A comparison of exception word, familiar face and affect processing in the left and right temporal variants of primary progressive aphasia. Cortex. 2016 Sep;82:147-163. doi: 10.1016/j.cortex.2016.05.014. Epub 2016 Jun 9.
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
その他の研究ID番号
- I-FACE CTSM162-25
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 (IPD) will not be shared because the data include sensitive clinical and neuropsychological information, and sharing could compromise participant confidentiality. The informed consent and ethics approval do not provide for public sharing of IPD. De-identified data may be considered for sharing upon reasonable request, subject to approval by the study investigators and applicable privacy and ethical requirements
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。