Alzheimer's Dementia (AD)NCT05254873
Long-term Follow-up of Patients Included in the EYE-TAR(MA) Study.
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(MA)-Follow-Up is a non-interventionel, long-term follow-up study in subjects who participated to the study referred as EYE-TAR(MA) (NCT04730440) EYE-TAR(MA)-Follow-Up aims to evaluate the long-term impacts of the Training of Affect Recognition TAR (an emotion recognition rehabilitation program), on social… 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?
- Long term follow-up
- How many people
- 7 participants
- Where
- 1 siteMonaco
- Study dates
- 21 Jan 2022to 11 Apr 2022
- 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: AD patients, who completed EYE-TAR(MA) study, and who have signed informed consent for this 2 years follow-up.
Who may be able to join
- Subjects who were included in the EYE-TAR (MA) study, and who completed this study.
- Subject accompanied by the caregiver already present during participation in the EYE-TAR (MA) study.
- Written informed consent signed by patient and family caregiver.
Who cannot join
None listed.
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: Long-term Follow-up of Patients Included in the EYE-TAR(MA) Study: 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(MA)-Follow-Up is a non-interventionel, long-term follow-up study in subjects who participated to the study referred as EYE-TAR(MA) (NCT04730440)
EYE-TAR(MA)-Follow-Up aims to evaluate the long-term impacts of the Training of Affect Recognition TAR (an emotion recognition rehabilitation program), on social cognition abilities, evolve gaze strategies, behavioral disorders, and the caregiver's burden in Alzheimer's disease (AD).
Subjects who completed EYE-TAR(MA) study, and who have signed informed consent for this follow-up, will be eligible to enroll. They will attend one visit two years post EYE-TAR(MA) study intervention (intervention was TAR, or a "classic" cognitive stimulation program) to undergo the following evaluation: Eye-tracking recording during Ekman Faces task, Mini Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), Zarit scale (completed by caregiver).
Read the detailed description
It is commonly admitted that social cognition impairment, like deficit in facial emotion recognition or misinterpretation of others' intentions (Theory of Mind), are associated with social behavior disorders.
This kind of disorders are observed in Fronto-Temporal Dementia (FTD), Alzheimer's Dementia (AD) and Parkinson's Disease (PD), with severe deficits in FTD and lighter deficits in AD and PD. One explanation is that patients apply inappropriate visual exploration strategies to decode emotions and intentions of others.
The study EYE-TAR(MA), NCT04730440, aimed to evaluate impacts of an emotion recognition rehabilitation program, named Training of Affect Recognition (TAR), on social cognition abilities (facial emotion recognition and theory of mind) in AD. In addition, investigators hypothesized that the effect of this rehabilitation will also evolve gaze strategies, behavioral disorders, and the caregiver's burden.
EYE-TAR(MA) results showed that participants who participated to the TAR (a) recognized facial emotions better and faster, especially sadness, fear and neutral expression; (b) evolved their gaze strategies on emotional faces with increased observation of the upper part of the face (nose and / or eyes); (c) had reduced behavioral disorders and the caregiver's burden. These results were specific to the TAR, since no significant change was observed in the AD-Control group who had participated in a "classic" cognitive stimulation program.
These changes were generally maintained one month after treatment.
Because there is not long-term follow-up data for these patients, Sponsor and investigators set-up the EYE-TAR(MA)-Follow-Up study to evaluate the long-term impacts of the Training of Affect Recognition, on social cognition abilities, evolve gaze strategies, behavioral disorders, and the caregiver's burden.
Subjects who completed EYE-TAR(MA) study, and who have signed informed consent for this follow-up, will be eligible to enroll. They will attend a visit two years post EYE-TAR(MA) study intervention to undergo the following evaluation: Eye-tracking recording during Ekman Faces task, Mini Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), Zarit scale (completed by caregiver).
- Conditions
- Alzheimer's Dementia (AD), Family Caregivers
- Being tested
- Long term follow-up
- Keywords
- Video-oculography, Eye-Tracking, Gaze strategies, Training of Affect Recognition, Emotion recognition, Behavioral disorders, Caregiver's burden, Alzheimer's Dementia, Oculomotor behaviors, Facial emotion recognition
- 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.
Long term follow-upOther
Long term follow-up for patient who completed the EYE-TAR(MA) study.
| Study group | Role | What they receive |
|---|---|---|
| AD-TAR | AD subjects who took part to Facial Emotion Recognition rehabilitation (TAR) during EYE-TAR(MA) study Receives: Other: Long term follow-up | |
| AD-Cognitive Stim | AD subjects who took part to cognitive stimulation session (12 sessions during 4 weeks) during EYE-TAR(MA) study Receives: Other: Long term follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial emotion recognition (FER) performances
Change from EYE-TAR(MA) Last evaluation and Comparison of FER performance between Long-term follow-up AD-TAR group and Long-term follow-up AD-Cognitive Stimulation group.
Evaluation criteria: Scores to Ekman Faces task (1976) and time to answer. 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: 2 years follow-up
Secondary outcomes (3)
Eye gaze strategies during Facial emotion recognition (FER)
Change from EYE-TAR(MA) Last evaluation and Comparison of gaze patterns between Long-term follow-up AD-TAR group and Long-term follow-up AD-Cognitive Stimulation group.
Evaluation criteria: Eye movements (number and 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: 2 years follow-up
Behavioral disorders
Change from EYE-TAR(MA) Last evaluation and Comparison between Long-term follow-up AD-TAR group and Long-term follow-up 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: 2 years follow-up
The Family caregiver's burden
Change from EYE-TAR(MA) Last evaluation and Comparison between Long-term follow-up AD-TAR group and Long-term follow-up 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: 2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start21 Jan 2022
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 7 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
- 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
- NCT05254873
- Sponsor's protocol ID
- EYE-TAR(MA)-FU
- Status last verified
- Dec 2023
- First submitted
- 14 Feb 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Patients Included in the EYE-TAR(MA) Study: 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
- NCT05254873
- Acronym / sponsor ID
- EYE-TAR(MA)-FU
- Conditions
- Alzheimer's Dementia (AD), Family Caregivers
- Keywords
- Video-oculography, Eye-Tracking, Gaze strategies, Training of Affect Recognition, Emotion recognition, Behavioral disorders, Caregiver's burden, Alzheimer's Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Association de Recherche Bibliographique pour les NeurosciencesUniversity, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 24 Feb 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(MA)-Follow-Up is a non-interventionel, long-term follow-up study in subjects who participated to the study referred as EYE-TAR(MA) (NCT04730440)
EYE-TAR(MA)-Follow-Up aims to evaluate the long-term impacts of the Training of Affect Recognition TAR (an emotion recognition rehabilitation program), on social cognition abilities, evolve gaze strategies, behavioral disorders, and the caregiver's burden in Alzheimer's disease (AD).
Subjects who completed EYE-TAR(MA) study, and who have signed informed consent for this follow-up, will be eligible to enroll. They will attend one visit two years post EYE-TAR(MA) study intervention (intervention was TAR, or a "classic" cognitive stimulation program) to undergo the following evaluation: Eye-tracking recording during Ekman Faces task, Mini Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), Zarit scale (completed by caregiver).
Detailed description
It is commonly admitted that social cognition impairment, like deficit in facial emotion recognition or misinterpretation of others' intentions (Theory of Mind), are associated with social behavior disorders.
This kind of disorders are observed in Fronto-Temporal Dementia (FTD), Alzheimer's Dementia (AD) and Parkinson's Disease (PD), with severe deficits in FTD and lighter deficits in AD and PD. One explanation is that patients apply inappropriate visual exploration strategies to decode emotions and intentions of others.
The study EYE-TAR(MA), NCT04730440, aimed to evaluate impacts of an emotion recognition rehabilitation program, named Training of Affect Recognition (TAR), on social cognition abilities (facial emotion recognition and theory of mind) in AD. In addition, investigators hypothesized that the effect of this rehabilitation will also evolve gaze strategies, behavioral disorders, and the caregiver's burden.
EYE-TAR(MA) results showed that participants who participated to the TAR (a) recognized facial emotions better and faster, especially sadness, fear and neutral expression; (b) evolved their gaze strategies on emotional faces with increased observation of the upper part of the face (nose and / or eyes); (c) had reduced behavioral disorders and the caregiver's burden. These results were specific to the TAR, since no significant change was observed in the AD-Control group who had participated in a "classic" cognitive stimulation program.
These changes were generally maintained one month after treatment.
Because there is not long-term follow-up data for these patients, Sponsor and investigators set-up the EYE-TAR(MA)-Follow-Up study to evaluate the long-term impacts of the Training of Affect Recognition, on social cognition abilities, evolve gaze strategies, behavioral disorders, and the caregiver's burden.
Subjects who completed EYE-TAR(MA) study, and who have signed informed consent for this follow-up, will be eligible to enroll. They will attend a visit two years post EYE-TAR(MA) study intervention to undergo the following evaluation: Eye-tracking recording during Ekman Faces task, Mini Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), Zarit scale (completed by caregiver).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD-TAR | – | Other: Long term follow-upAD subjects who took part to Facial Emotion Recognition rehabilitation (TAR) during EYE-TAR(MA) study |
| AD-Cognitive Stim | – | Other: Long term follow-upAD subjects who took part to cognitive stimulation session (12 sessions during 4 weeks) during EYE-TAR(MA) study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AD patients, who completed EYE-TAR(MA) study, and who have signed informed consent for this 2 years follow-up.
Key inclusion criteria (3 listed)
- Subjects who were included in the EYE-TAR (MA) study, and who completed this study.
- Subject accompanied by the caregiver already present during participation in the EYE-TAR (MA) study.
- Written informed consent signed by patient and family caregiver.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Long term follow-upLong term follow-up for patient who completed the EYE-TAR(MA) study. | Other | AD-Cognitive Stim, AD-TAR |
Primary outcome
Facial emotion recognition (FER) performances
Time frame: 2 years follow-up
Change from EYE-TAR(MA) Last evaluation and Comparison of FER performance between Long-term follow-up AD-TAR group and Long-term follow-up AD-Cognitive Stimulation group. Evaluation criteria: Scores to Ekman Faces task (1976) and time to answer. 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.
3 secondary outcomes
Eye gaze strategies during Facial emotion recognition (FER)
Time frame: 2 years follow-up
Behavioral disorders
Time frame: 2 years follow-up
The Family caregiver's burden
Time frame: 2 years follow-up
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 15 Dec 2023.
- Polet K, \& al. Remédiation de la reconnaissance des émotions faciales dans la maladie d'Alzheimer et effets sur les stratégies d'observation, les troubles du comportement et le fardeau de l'aidant. Neurol psychiatr gériatr, 2021 ; 21(12Link provided by the sponsor.
- Mirzai M, \& al. Long-term effects of rehabilitation of facial emotion recognition and its clinical consequences in Alzheimer's diseaseLink provided by the sponsor.
- 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 3 inclusion and 0 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 15 Dec 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: 2 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2023.