NCT05267028

Brief 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) 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

February 14, 2022

Last Update Submit

March 29, 2023

Conditions

Alzheimer's Dementia (AD)Family Caregivers

Keywords

Facial emotion recognitionTraining of Affect RecognitionBehavioral disordersCaregiver's burdenAlzheimer's DementiaGaze strategiesEye-TrackingOculomotor behaviors

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline; Week 6; 1 month post intervention

Secondary Outcomes (8)

  • Facial emotion recognition (FER) performances - Response times

    Baseline; Week 6; 1 month post intervention

  • Facial emotion recognition (FER) performances - Response times (dynamic set)

    Baseline; Week 6; 1 month post intervention

  • Eye movements behaviors during Facial emotion recognition (FER)

    Baseline; Week 6; 1 month post intervention

  • Eye-Tracking Measurements during Facial emotion recognition (FER)

    Baseline; Week 6; 1 month post intervention

  • Eye gaze strategies during Facial emotion recognition (FER) (dynamic set)

    Baseline; Week 6; 1 month post intervention

  • +3 more secondary outcomes

Study Arms (2)

AD-TAR

AD subjects who take part to Facial Emotion Recognition rehabilitation (TAR)

Other: AD-TAR

AD-Cognitive Stimulation

AD subjects who take part to cognitive stimulation session (12 sessions during 4 weeks)

Other: AD-Cognitive Stimulation

Interventions

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-TAR
AD-Cognitive StimulationOTHER

12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using classic cognitive stimulation workshops.

AD-Cognitive Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital

Monaco, 98000, Monaco

Location

MeSH Terms

Conditions

Alzheimer DiseaseMental Disorders

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive Disorders

Study Officials

  • Sandrine LOUCHART DE LA CHAPELLE, MD PhD

    Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2022

First Posted

March 4, 2022

Study Start

February 10, 2022

Primary Completion

March 22, 2023

Study Completion

March 22, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)