StrokeI-FACENCT07911878
Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
An observational study of Stroke and Alzheimer s Disease, run by Istituti Clinici Scientifici Maugeri SpA at 10 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Alzheimer s Disease, Frontotemporal Degeneration (FTD)
- What is being tested?
- Neuropsychological assessment using the I-FACE battery
- How many people
- 300 participants
- Where
- 10 sitesItaly
- Study dates
- 5 Sep 2025to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
- Diagnosis of probable FTD according to established clinical criteria. Age 40-85 years. Ability to provide informed consent.
- Diagnosis of probable AD according to established clinical criteria. Age 40-85 years. Ability to provide informed consent.
- Subacute phase: 1 week to 3 months post-event. Ischemic or hemorrhagic stroke confirmed by neuroimaging and/or clinical judgment.
Who cannot join
- Uncorrected vision or hearing impairment.
- Frontotemporal Dementia (FTD) Patients
- 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
Show all 11Show fewer
- 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
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Italy10 sites, 10 recruiting
- Recruiting
Istituti Clinici Scientifici Maugeri IRCCS Bari
Bari, 70124
Serena Tagliente, MSc, +390807814331, serena.tagliente@icsmaugeri.it
Stefania De Trane, MD, stefania.detrane@icsmaugeri.it
- Not yet recruiting
IRCCS Maugeri Castel Goffredo
Castel Goffredo, MN, 46042
Giuliana Vezzadini, MD, giuliana.vezzadini@icsmaugeri.it
- Recruiting
IRCCS Maugeri Lumezzane
Lumezzane, BS, 25065
Lidia Gazzi, MSc, +39 030 825 3011, lidia.gazzi@icsmaugeri.it
Gaia C Santi, PhD, +39 030 825 3011, gaia.santi@icsmaugeri.it
- Recruiting
Istituti Clinici Scientifici Maugeri IRCCS Milano
Milan, 20138
Christian Lunetta, MD, +39 02 5072 5266, christian.lunetta@icsmaugeri.it
Claudia Bossi, MSc, +39 0382 592048, claudia.bossi@icsmaugeri.it
- Recruiting
ICS Maugeri Mistretta
Mistretta, ME, 98073
Luisa Scaduto, MSc, 0921 389111, luisa.scaduto@icsmaugeri.it
- Recruiting
IRCCS Maugeri Montescano
Montescano, PV, 27040
Antonia Pierobon, MSc, 0385 2471, antonia.pierobon@icsmaugeri.it
- Recruiting
IRCCS Maugeri Pavia
Pavia, 27100
Marina Manera, MSc, 0382 592952, marina.manera@icsmaugeri.it
- Recruiting
ICS Maugeri Sciacca
Sciacca, AG, 92019
Stefania Ruvolo, MSc, stefania.ruvolo@icsmaugeri.it
- Recruiting
IRCCS Maugeri Telese Terme
Telese Terme, 82037
Pasquale Moretta, MSc, +39 0824 909111, pasquale.moretta@icsmaugeri.it
- Not yet recruiting
IRCCS Maugeri Veruno
Veruno, 28013
Giusy Figliano, PhD, 0322 884711, giusi.figliano@icsmaugeri.it
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Neuropsychological assessment using the I-FACE battery
- Keywords
- Famous-face recognition, Neuropsychological assessment, Neurodegenerative diseases
- Medical subject headings
- Stroke, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessment using the I-FACE batteryDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Control participants will be administered the experimental neuropsychological battery to establish normative data. Receives: Diagnostic Test: Neuropsychological assessment using the I-FACE battery | |
| Patients with Alzheimer's disease | Patients with AD will be administered the experimental neuropsychological battery to establish the clinical validity of the FAME Receives: Diagnostic Test: Neuropsychological assessment using the I-FACE battery | |
| Patients with Frontotemporal dementia | Patients with FTD will be administered the experimental neuropsychological battery to establish the clinical validity of the FAME Receives: Diagnostic Test: Neuropsychological assessment using the I-FACE battery | |
| Post-stroke survivors | Post-stroke survivors will be administered the experimental neuropsychological battery to establish the clinical validity of the FAME Receives: Diagnostic Test: Neuropsychological assessment using the I-FACE battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
I-FACE total and subtest scores
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.
Measured: From enrollment to the end of neuropsychologic assessment (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start5 Sep 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petronilla Battista, PhD, Principal investigator, Istituti Clinici Scientifici Maugeri IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911878
- Sponsor's protocol ID
- I-FACE CTSM162-25
- Acronym
- I-FACE
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 11571224Gainotti 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.
PubMed 25697904Chan 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.
PubMed 19297506Bruce 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.
PubMed 3756376Brambati 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.
PubMed 20600979Blank 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.
PubMed 25451765Bizzozero 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.
PubMed 18175078Binney 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.
PubMed 27389800
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sviluppo, Validazione e Dati Normativi Della Batteria Italiana Per il Riconoscimento Dei Volti Famosi I-FACE
- ClinicalTrials.gov ID
- NCT07911878
- Acronym / sponsor ID
- I-FACE / I-FACE CTSM162-25
- Keywords
- Famous-face recognition, Neuropsychological assessment, Neurodegenerative diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Diagnostic Test: Neuropsychological assessment using the I-FACE batteryControl participants will be administered the experimental neuropsychological battery to establish normative data. |
| Patients with Alzheimer's disease | – | Diagnostic Test: Neuropsychological assessment using the I-FACE batteryPatients with AD will be administered the experimental neuropsychological battery to establish the clinical validity of the FAME |
| Patients with Frontotemporal dementia | – | Diagnostic Test: Neuropsychological assessment using the I-FACE batteryPatients with FTD will be administered the experimental neuropsychological battery to establish the clinical validity of the FAME |
| Post-stroke survivors | – | Diagnostic Test: Neuropsychological assessment using the I-FACE batteryPost-stroke survivors will be administered the experimental neuropsychological battery to establish the clinical validity of the FAME |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
- Diagnosis of probable FTD according to established clinical criteria. Age 40-85 years. Ability to provide informed consent.
- Diagnosis of probable AD according to established clinical criteria. Age 40-85 years. Ability to provide informed consent.
Key exclusion criteria (11 listed)
- Uncorrected vision or hearing impairment.
- Frontotemporal Dementia (FTD) Patients
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological assessment using the I-FACE batteryParticipants 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. | Diagnostic test | Healthy controls, Patients with Alzheimer's disease, Patients with Frontotemporal dementia, Post-stroke survivors |
Primary outcome
I-FACE total and subtest scores
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 11571224Gorno-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.
- Background: PubMed 25697904Gainotti 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.
- Background: PubMed 19297506Chan 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.
- Background: PubMed 3756376Bruce 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.
- Background: PubMed 20600979Brambati 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.
- Background: PubMed 25451765Blank 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.
- Background: PubMed 18175078Bizzozero 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.
- Background: PubMed 27389800Binney 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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petronilla Battista, PhD principal investigator
Istituti Clinici Scientifici Maugeri IRCCS
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Alzheimer s Disease, run by Istituti Clinici Scientifici Maugeri SpA at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petronilla Battista, PhD (+39 0807814331, petronilla.battista@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I-FACE total and subtest scores (time frame: From enrollment to the end of neuropsychologic assessment (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07911878, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.