此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME) (I-FACE)

2026年11月2日 更新者:Istituti Clinici Scientifici Maugeri SpA

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Bari、意大利、70124
      • Milan、意大利、20138
        • 招聘中
        • Istituti Clinici Scientifici Maugeri IRCCS Milano
        • 接触:
        • 接触:
        • 副研究员:
          • Debora Pain, MSc
      • Pavia、意大利、27100
      • Telese Terme、意大利、82037
      • Veruno、意大利、28013
    • AG
    • BS
      • Lumezzane、BS、意大利、25065
    • ME
      • Mistretta、ME、意大利、98073
    • MN
      • Castel Goffredo、MN、意大利、46042
    • PV
      • Montescano、PV、意大利、27040

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 85年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

  1. 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.

  2. 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.

  3. 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.

  4. 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
I-FACE total and subtest scores
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Petronilla Battista, PhD、Istituti Clinici Scientifici Maugeri IRCCS

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月5日

初级完成 (估计的)

2028年1月31日

研究完成 (估计的)

2028年9月30日

研究注册日期

首次提交

2026年10月23日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月3日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅