Alzheimer's Dementia (AD)NCT05267028
Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease
An observational study of Alzheimer's Dementia (AD) and Family Caregivers, run by Association de Recherche Bibliographique pour les Neurosciences at 1 site in Monaco.
Trial summary
EYE-TAR(AD+) is an observational study based on the same design as the princeps EYE-TAR(MA) study, but with a larger number of patients and including an additional evaluation of Facial emotion recognition (based on a more ecological material), in order to reinforce conclusions of the study EYE-TAR(MA)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer's Dementia (AD), Family Caregivers
- What is being tested?
- AD-TAR and AD-Cognitive Stimulation
- How many people
- 16 participants
- Where
- 1 siteMonaco
- Study dates
- 10 Feb 2022to 22 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed at the Memory Center of the Rainier III Center, presenting a neurodegenerative pathology of the AD type, for whom participation in workshops (remediation of the recognition of facial emotions and cognitive stimulation) led by a neuropsychologist, is recommended.
Who may be able to join
- Male or Female.
- AD diagnosed according to l'IWG-2 (Dubois \& al. 2014) criteria,
- Mini-Mental State (MMS-E) ≥15
- Subject accompanied by a family caregiver and whose participation in a cognitive stimulation workshop was recommended in Memory Centre of the RAINIER Centre (Princesses Grace Hospital - Monaco)
- Written informed consent signed by patient and family caregiver.
Who cannot join
- General anaesthesia within 3 months.
- History of psychiatric and/or neurological disorder (other than the diagnosed neurodegenerative pathology);
- History of alcoholism or drug addiction
- Ophthalmological or neurological problems preventing a video-oculography examination.
- Oculomotor disorders such as "fixation disorders" or "ocular tracking disorders".
- Cognitive disorders of the neurovisual type (visual agnosia, prosopagnosia, visuo-spatial disorder or visuo-perceptual disorder) or aphasia.
Trial locations and contacts
1 site in 1 country.
Monaco1 site
Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Monaco, 98000
About this study
Official title: Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease and Study of the Consequences on Gaze Strategy, Behavior Disorders and Family Caregivers' Burden
EYE-TAR(AD+) is an observational study based on the same design as the princeps EYE-TAR(MA) study, but with a larger number of patients and including an additional evaluation of Facial emotion recognition (based on a more ecological material), in order to reinforce conclusions of the study EYE-TAR(MA) https://doi.org/10.1016/j.npg.2020.08.003.
The main objective is to confirm that facial emotion recognition can be improved in AD using the "Training of Affect Recognition program" (TAR).
Read more
The Secondary Objectives are to:
Evaluate the impact of the "Training of Affect Recognition program" (TAR) on oculomotor behavior in a situation of social cognition, on behavioral disorders and on caregiver burden.
Confirm that improvement in facial emotion recognition is related to modification of observation strategies.
Confirm the link between improved recognition of facial emotions, reduced behavioral disorders and caregiver burden.
- Conditions
- Alzheimer's Dementia (AD), Family Caregivers
- Being tested
- AD-TAR, AD-Cognitive Stimulation
- Keywords
- Facial emotion recognition, Training of Affect Recognition, Behavioral disorders, Caregiver's burden, Alzheimer's Dementia, Gaze strategies, Eye-Tracking, Oculomotor behaviors
- Medical subject headings
- Alzheimer Disease, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-TAROther
12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using a rehabilitation program named Training of Affect Recognition (TAR).
AD-Cognitive StimulationOther
12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using classic cognitive stimulation workshops.
| Study group | Role | What they receive |
|---|---|---|
| AD-TAR | AD subjects who take part to Facial Emotion Recognition rehabilitation (TAR) Receives: Other: AD-TAR | |
| AD-Cognitive Stimulation | AD subjects who take part to cognitive stimulation session (12 sessions during 4 weeks) Receives: Other: AD-Cognitive Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial emotion recognition (FER) performances
Change from Baseline and Comparison of FER performance between AD-TAR group and AD-Cognitive Stimulation group.
Evaluation criteria: Scores to Ekman Faces task (1976). FER was assessed using pictures from the Ekman Faces task (1976), to test the recognition of the six facial basic emotions and neutral faces. There were four pictures per emotion, for a total of 28. For each picture, participants were asked to select one of the seven labels (anger, disgust, fear, sadness, happiness, surprise and neutral), with a maximum of 8 seconds of response time per picture.
Measured: Baseline; Week 6; 1 month post intervention
Facial emotion recognition (FER) performances (dynamic set)
Change from Baseline and Comparison of FER performance between AD-TAR group and AD-Cognitive Stimulation group.
Evaluation criteria: Scores to the Amsterdam Dynamic Facial Expression Set (ADFES).
FER was assessed using pictures from the Amsterdam Dynamic Facial Expression Set (ADFES/ Van Der Schalk J, Hawk ST, Fischer AH, Doosje B. Moving faces, looking places: validation of the Amsterdam Dynamic Facial Expression Set (ADFES). Emotion. 2011;11(4):907-20.), to test the recognition of the six facial basic emotions and neutral faces. There were four pictures per emotion, for a total of 28. For each picture, participants were asked to select one of the seven labels (anger, disgust, fear, sadness, happiness, surprise and neutral), with a maximum of 8 seconds of response time per picture.
Measured: Baseline; Week 6; 1 month post intervention
Secondary outcomes (8)
Facial emotion recognition (FER) performances - Response times
Change from Baseline and Comparison of FER performance between AD-TAR group and AD-Cognitive Stimulation group.
Evaluation criteria: Response times to identify pictures from the Ekman Faces task (1976).
Measured: Baseline; Week 6; 1 month post intervention
Facial emotion recognition (FER) performances - Response times (dynamic set)
Change from Baseline and Comparison of FER performance between AD-TAR group and AD-Cognitive Stimulation group.
Evaluation criteria: Response time to identify dynamic expressions from the Amsterdam Dynamic Facial Expression Set (ADFES).
Measured: Baseline; Week 6; 1 month post intervention
Eye movements behaviors during Facial emotion recognition (FER)
Change from Baseline and Comparison of gaze patterns between AD-TAR group and AD-Cognitive Stimulation group, during Facial emotion recognition tasks.
Evaluation criteria: Eye movements (number of fixations on areas of interest) recorded with an eye-tracking device. FER was assessed using some pictures from the Ekman Faces task (1976).
Measured: Baseline; Week 6; 1 month post intervention
Eye-Tracking Measurements during Facial emotion recognition (FER)
Change from Baseline and Comparison of gaze patterns between AD-TAR group and AD-Cognitive Stimulation group, during Facial emotion recognition tasks.
Evaluation criteria: Eye movements (duration of fixations on areas of interest) recorded with an eye-tracking device. FER was assessed using some pictures from the Ekman Faces task (1976).
Measured: Baseline; Week 6; 1 month post intervention
Eye gaze strategies during Facial emotion recognition (FER) (dynamic set)
Change from Baseline and Comparison of gaze patterns between AD-TAR group and AD-Cognitive Stimulation group, during Facial emotion recognition tasks.
Evaluation criteria: Eye movements (timeline of eye fixations on areas of interest) recorded with a gaze recording device Tobii. FER was assessed using some pictures from the Amsterdam Dynamic Facial Expression Set (ADFES - 2011).
Measured: Baseline; Week 6; 1 month post intervention
Behavioral disorders
Change from Baseline and Comparison between AD-TAR group and AD-Cognitive Stimulation group, Evaluation criteria: Neuropsychiatric Inventory (NPI), a scale that includes ten behavioral items (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability and aberrant motor behaviors) and two neurovegetative symptoms (sleep and appetite disorders). The evaluation was based on an interview with patients' primary caregivers. Both the frequency (/5) and the severity (/3) of each behavior were determined and a score was calculated by multiplying the frequency and the severity of each behavior observed during the last month.
Measured: Baseline; Week 6; 1 month post intervention
The Family caregiver's burden
Change from Baseline and Comparison between AD-TAR group and AD-Cognitive Stimulation group, Evaluation criteria: The burden of the family caregiver was measured with the Zarit scale (completed by the caregiver). Composed of 22 questions on the physical, emotional and financial load felt. Total score /88.
Measured: Baseline; Week 6; 1 month post intervention
Global cognitive performance
Change from Baseline and Comparison between AD-TAR group and AD-Cognitive Stimulation group, Evaluation criteria: MMSE (MINI MENTAL STATE EXAMINATION). 30-question general cognitive function assessment. The maximum score is 30.
Measured: Baseline; Week 6; 1 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start10 Feb 2022
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's Dementia (AD)Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association de Recherche Bibliographique pour les Neurosciences
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace, Universite Cote d'Azur
- Responsible party
- Sponsor
- Investigators
- Sandrine LOUCHART DE LA CHAPELLE, MD PhD, Principal investigator, Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267028
- Sponsor's protocol ID
- EYE-TAR(AD+)
- Status last verified
- Mar 2023
- First submitted
- 14 Feb 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mirzai N, Galy E, Louchart de la Chapelle S, Hesse S, Morisot A, Pesce A, Polet K. Facial Emotion Recognition Ability May Improve in Alzheimer Disease: A Pilot Study. Cogn Behav Neurol. 2026 Mar 1;39(1):14-31. doi: 10.1097/WNN.0000000000000416.
PubMed 41566791
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease and Study of the Consequences on Gaze Strategy, Behavior Disorders and Family Caregivers' Burden
- ClinicalTrials.gov ID
- NCT05267028
- Acronym / sponsor ID
- EYE-TAR(AD+)
- Conditions
- Alzheimer's Dementia (AD), Family Caregivers
- Keywords
- Facial emotion recognition, Training of Affect Recognition, Behavioral disorders, Caregiver's burden, Alzheimer's Dementia, Gaze strategies, Eye-Tracking, Oculomotor behaviors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Association de Recherche Bibliographique pour les NeurosciencesUniversity, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace, Universite Cote d'Azur
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 4 Mar 2022 (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.
EYE-TAR(AD+) is an observational study based on the same design as the princeps EYE-TAR(MA) study, but with a larger number of patients and including an additional evaluation of Facial emotion recognition (based on a more ecological material), in order to reinforce conclusions of the study EYE-TAR(MA) https://doi.org/10.1016/j.npg.2020.08.003.
The main objective is to confirm that facial emotion recognition can be improved in AD using the "Training of Affect Recognition program" (TAR).
The Secondary Objectives are to:
Evaluate the impact of the "Training of Affect Recognition program" (TAR) on oculomotor behavior in a situation of social cognition, on behavioral disorders and on caregiver burden.
Confirm that improvement in facial emotion recognition is related to modification of observation strategies.
Confirm the link between improved recognition of facial emotions, reduced behavioral disorders and caregiver burden.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD-TAR | – | Other: AD-TARAD subjects who take part to Facial Emotion Recognition rehabilitation (TAR) |
| AD-Cognitive Stimulation | – | Other: AD-Cognitive StimulationAD subjects who take part to cognitive stimulation session (12 sessions during 4 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed at the Memory Center of the Rainier III Center, presenting a neurodegenerative pathology of the AD type, for whom participation in workshops (remediation of the recognition of facial emotions and cognitive stimulation) led by a neuropsychologist, is recommended.
Key inclusion criteria (5 listed)
- Male or Female.
- AD diagnosed according to l'IWG-2 (Dubois \& al. 2014) criteria,
- Mini-Mental State (MMS-E) ≥15
- Subject accompanied by a family caregiver and whose participation in a cognitive stimulation workshop was recommended in Memory Centre of the RAINIER Centre (Princesses Grace Hospital - Monaco)
- Written informed consent signed by patient and family caregiver.
Key exclusion criteria (6 listed)
- General anaesthesia within 3 months.
- History of psychiatric and/or neurological disorder (other than the diagnosed neurodegenerative pathology);
- History of alcoholism or drug addiction
- Ophthalmological or neurological problems preventing a video-oculography examination.
- Oculomotor disorders such as "fixation disorders" or "ocular tracking disorders".
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 |
|---|---|---|
| AD-TAR12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using a rehabilitation program named Training of Affect Recognition (TAR). | Other | AD-TAR |
| AD-Cognitive Stimulation12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using classic cognitive stimulation workshops. | Other | AD-Cognitive Stimulation |
Primary outcome
Facial emotion recognition (FER) performances
Time frame: Baseline; Week 6; 1 month post intervention
Change from Baseline and Comparison of FER performance between AD-TAR group and AD-Cognitive Stimulation group. Evaluation criteria: Scores to Ekman Faces task (1976). FER was assessed using pictures from the Ekman Faces task (1976), to test the recognition of the six facial basic emotions and neutral faces. There were four pictures per emotion, for a total of 28. For each picture, participants were asked to select one of the seven labels (anger, disgust, fear, sadness, happiness, surprise and neutral), with a maximum of 8 seconds of response time per picture.
Facial emotion recognition (FER) performances (dynamic set)
Time frame: Baseline; Week 6; 1 month post intervention
Change from Baseline and Comparison of FER performance between AD-TAR group and AD-Cognitive Stimulation group. Evaluation criteria: Scores to the Amsterdam Dynamic Facial Expression Set (ADFES). FER was assessed using pictures from the Amsterdam Dynamic Facial Expression Set (ADFES/ Van Der Schalk J, Hawk ST, Fischer AH, Doosje B. Moving faces, looking places: validation of the Amsterdam Dynamic Facial Expression Set (ADFES). Emotion. 2011;11(4):907-20.), to test the recognition of the six facial basic emotions and neutral faces. There were four pictures per emotion, for a total of 28. For each picture, participants were asked to select one of the seven labels (anger, disgust, fear, sadness, happiness, surprise and neutral), with a maximum of 8 seconds of response time per picture.
8 secondary outcomes
Facial emotion recognition (FER) performances - Response times
Time frame: Baseline; Week 6; 1 month post intervention
Facial emotion recognition (FER) performances - Response times (dynamic set)
Time frame: Baseline; Week 6; 1 month post intervention
Eye movements behaviors during Facial emotion recognition (FER)
Time frame: Baseline; Week 6; 1 month post intervention
Eye-Tracking Measurements during Facial emotion recognition (FER)
Time frame: Baseline; Week 6; 1 month post intervention
Eye gaze strategies during Facial emotion recognition (FER) (dynamic set)
Time frame: Baseline; Week 6; 1 month post intervention
Behavioral disorders
Time frame: Baseline; Week 6; 1 month post intervention
The Family caregiver's burden
Time frame: Baseline; Week 6; 1 month post intervention
Global cognitive performance
Time frame: Baseline; Week 6; 1 month post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Derived from this study: PubMed 41566791Mirzai N, Galy E, Louchart de la Chapelle S, Hesse S, Morisot A, Pesce A, Polet K. Facial Emotion Recognition Ability May Improve in Alzheimer Disease: A Pilot Study. Cogn Behav Neurol. 2026 Mar 1;39(1):14-31. doi: 10.1097/WNN.0000000000000416.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sandrine LOUCHART DE LA CHAPELLE, MD PhD principal investigator
Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Dementia (AD) and Family Caregivers, run by Association de Recherche Bibliographique pour les Neurosciences at 1 site in Monaco.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Monaco. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial emotion recognition (FER) performances (time frame: Baseline; Week 6; 1 month post intervention). The study lists 2 primary outcomes in all. 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 NCT05267028, which also lists 1 linked publication.
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 31 Mar 2023.