NCT04730440

Brief Summary

This study aims to evaluate impacts of an emotion recognition rehabilitation program, named Training of Affect Recognition, on social cognition abilities in Alzheimer's disease (AD). In addition, we hypothesis that the effect of this rehabilitation will also evolve gaze strategies, behavioral disorders, and the caregiver's burden.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

January 26, 2021

Last Update Submit

January 26, 2021

Conditions

Alzheimer DementiaFamily Caregivers

Keywords

Video-oculographyEye-TrackingGaze strategiesOculomotor behaviorsTraining of Affect RecognitionEmotion recognitionFacial emotion recognitionTheory of Mind (ToM)Behavioral disordersCaregiver's burdenAlzheimer's Dementia

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) 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.

    Baseline; Week 6; 1 month post intervention

  • Affective ToM performances

    Change from Baseline and Comparison of Affective ToM performance between AD-TAR group and AD-Cognitive Stimulation group. Evaluation criteria: Scores to the " Reading the Mind in the Eyes " test (Baron-Cohen 2001). 36 black-and-white photographs of the eye area of faces. Subjets are asked to choose which word, among four options, best described what the character in the photograph was thinking or feeling. For this task, four scores were obtained: a total score (/36) and three emotional valence sub-scores: positive (/8), neutral (/16) and negative (/12).

    Baseline; Week 6; 1 month post intervention

Secondary Outcomes (4)

  • Eye gaze strategies during Facial emotion recognition (FER)

    Baseline; Week 6; 1 month post intervention

  • Behavioral disorders

    Baseline; Week 6; 1 month post intervention

  • The Family caregiver's burden

    Baseline; Week 6; 1 month post intervention

  • Global cognitive performance

    Baseline; Week 6; 1 month post intervention

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

Intervention description: 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

Intervention description: 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

Patient with an Alzheimer's disease and with a Mini-Mental State score ≥15

You may qualify if:

  • 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.
  • Ophthalmological or neurological problems preventing a video-oculography examination.
  • Oculomotor disorders such as "fixation disorders" or "ocular tracking disorders".
  • Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.
  • History of bipolar disorder or schizophrenia
  • History of alcohol abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseMental Disorders

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive Disorders

Study Design

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

Study Record Dates

First Submitted

January 26, 2021

First Posted

January 29, 2021

Study Start

March 1, 2019

Primary Completion

March 26, 2020

Study Completion

March 26, 2020

Last Updated

January 29, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share