An observational study in Alzheimer's Dementia (AD) and Family Caregivers, sponsored by Association de Recherche Bibliographique pour les Neurosciences. Completed at 1 site in Monaco. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by Association de Recherche Bibliographique pour les Neurosciences · Observational
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 16 is below the median of 200 across 814 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Association de Recherche Bibliographique pour les Neurosciences is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AD subjects who take part to Facial Emotion Recognition rehabilitation (TAR)
Other: AD-TAR
AD subjects who take part to cognitive stimulation session (12 sessions during 4 weeks)
Other: AD-Cognitive Stimulation
12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using a rehabilitation program named Training of Affect Recognition (TAR).
12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using classic cognitive stimulation workshops.
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.
Time frame: 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.
Time frame: Baseline; Week 6; 1 month post intervention
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; Week 6; 1 month post intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2022 to primary completion in Mar 2023, 13 months.
Of 364 non-industry observational studies under Alzheimer Disease, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 203. This study's 13 months is below that.
Counting every sponsor, half of 405 studies reached it within 67 months; a quarter within 35 and three quarters within 171.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Association de Recherche Bibliographique pour les Neurosciences