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

2 november 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

300

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

      • Bari, Italië, 70124
      • Milan, Italië, 20138
        • Werving
        • Istituti Clinici Scientifici Maugeri IRCCS Milano
        • Contact:
        • Contact:
        • Onderonderzoeker:
          • Debora Pain, MSc
      • Pavia, Italië, 27100
      • Telese Terme, Italië, 82037
      • Veruno, Italië, 28013
        • Nog niet aan het werven
        • IRCCS Maugeri Veruno
        • Contact:
    • AG
    • BS
      • Lumezzane, BS, Italië, 25065
    • ME
      • Mistretta, ME, Italië, 98073
    • MN
      • Castel Goffredo, MN, Italië, 46042
    • PV
      • Montescano, PV, Italië, 27040

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

  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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
I-FACE total and subtest scores
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Petronilla Battista, PhD, Istituti Clinici Scientifici Maugeri IRCCS

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 september 2025

Primaire voltooiing (Geschat)

31 januari 2028

Studie voltooiing (Geschat)

30 september 2028

Studieregistratiedata

Eerst ingediend

23 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 november 2026

Eerst geplaatst (Werkelijk)

3 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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