NCT05254873

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

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

January 21, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

February 14, 2022

Last Update Submit

December 11, 2023

Conditions

Alzheimer's Dementia (AD)Family Caregivers

Keywords

Video-oculographyEye-TrackingGaze strategiesTraining of Affect RecognitionEmotion recognitionBehavioral disordersCaregiver's burdenAlzheimer's DementiaOculomotor behaviorsFacial emotion recognition

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years follow-up

Secondary Outcomes (3)

  • Eye gaze strategies during Facial emotion recognition (FER)

    2 years follow-up

  • Behavioral disorders

    2 years follow-up

  • The Family caregiver's burden

    2 years follow-up

Study Arms (2)

AD-TAR

AD subjects who took part to Facial Emotion Recognition rehabilitation (TAR) during EYE-TAR(MA) study

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

Other: Long term follow-up

Interventions

Long term follow-upOTHER

Long term follow-up for patient who completed the EYE-TAR(MA) study.

AD-Cognitive StimAD-TAR

Eligibility Criteria

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

AD patients, who completed EYE-TAR(MA) study, and who have signed informed consent for this 2 years follow-up.

You may qualify if:

  • 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.

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

Related Links

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
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2022

First Posted

February 24, 2022

Study Start

January 21, 2022

Primary Completion

April 11, 2022

Study Completion

April 11, 2022

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)