Emotion and Attention in Alzheimer's Disease (ATEMMA) (ATEMMA)

Attentional Capture by Emotional Information in Alzheimer's Disease : an fMRI Study

The main purpose of this study is to investigate the existence of emotional attention impairments in Alzheimer's Disease, in correlation with amygdala and attention networks alterations. To this end, functional and structural neuroimaging will be used. A face expression recognition task, along with eyetracking, will be used to assess emotional attention impairments.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Behavioral: Facial expression recognition task

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • La Tronche, France
    • Grenoble University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers :

  • Affiliation to social security
  • Medical examination before study participation
  • No contraindication to MRI
  • Informed consent signed
  • Young adults older than 18 years and younger than 40 years
  • Healthy old adults older than 65 years and younger than 95 years
  • Visual acuity allowing normal perception of stimuli or corrected to normal vision

• Patients with Alzheimer's Disease :

  • Affiliation to social security
  • Medical examination before study participation
  • No contraindication to MRI
  • Informed consent signed
  • Patients with Alzheimer's Disease at mild or moderate stage (National Institute on Aging and Alzheimer's Association criteria), diagnosed at Grenoble CMRR (Centre Mémoire de Ressources et de Recherche)
  • Patients older than 65 years and younger than 95 years
  • MMSE (Mini-Mental State Examination) > 18/30
  • Ability to understand study instructions and give an informed consent
  • Visual acuity allowing normal perception of stimuli or corrected to normal vision

Exclusion Criteria:

• Every participant having a vascular stent implanted less than 6 weeks before study
• Every participant having a biomedical material implanted that is considered "unsafe" in the list: http://www.mrisafety.com/TheList_search.asp
• Every acquisition procedure not respecting required conditions by the "conditional" usage in a participant having a biomedical material implanted that is considered "conditional" in the list: http://www.mrisafety.com/TheList_search.asp
• Every subject having a biomedical material such as a cardiac, neuronal or sensorial stimulator (cochlear implant because of demagnetization, electrode heating or artefact risk) or a ventricular drain without trained medical or paramedical support during MRI for these participants
• Ferromagnetic object inside the eye or the skull, close to nervous structures (displacement and complications risk such as eye or brain damage)
• Claustrophobia
• Psychiatric (e.g., bipolar disorder) or neurological pathology (e.g., epilepsy, Parkinson's Disease) other than Alzheimer's Disease
• Non cooperating participant
• Severe and uncontrolled affection: cardiac, respiratory, haematological, renal, hepatic, cancerous
• Participation to other research protocols with exclusion period or MRI during the past weel
• Drug therapy likely to modulate brain activity : neuroleptics, lithium, etc...
• Alcohol ingestion before study
• Participants concerned by articles L1125-5 to L1121-8 of CSP (Code de la Santé Publique) (pregnant or nursing women, underage or protected adult, person under administrative or judicial oversight
• Participant receiving more than 4500 euros for his participation to other studies involving human person during the past 12 months before this study
• Participant unable to be contacted in case of emergency
• Inability to understand study instructions or give an informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Young adults; Participants aged between 18 and 40 years old.	Behavioral: Facial expression recognition task; We will present emotional expressions to participants. Their task will be to determine which emotion is expressed by each face. Participants' eye movements and brain activity will be recorded while they explore the face.
Active Comparator: Healthy old adults; Participants aged between 65 and 95 years old.	Behavioral: Facial expression recognition task; We will present emotional expressions to participants. Their task will be to determine which emotion is expressed by each face. Participants' eye movements and brain activity will be recorded while they explore the face.
Experimental: Patients with Alzheimer's Disease; Participants aged between 65 and 95 years old with a diagnosis of Alzheimer's Disease.	Behavioral: Facial expression recognition task; We will present emotional expressions to participants. Their task will be to determine which emotion is expressed by each face. Participants' eye movements and brain activity will be recorded while they explore the face.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Classic recognition score	Facial expression recognition score (%)	1 hour
Classic fixation time faces	Fixation time on eyes as measured with eyetracking (ms)	1 hour
Fixation time scenes	Fixation time on emotional scenes outside of MRI	30 mn
Classic fMRI activity	fMRI activity in amygdala and emotional attention networks during face exploration and resting-state	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alternative recognition score	Facial expression recognition score (%) during an alternative task designed to encourage focus on the eyes	1 hour
Alternative fixation time faces	Fixation time on eyes as measured with eyetracking (ms) during this alternative task.	1 hour
Alternative fMRI activity	fMRI activity in amygdala and emotional attention networks during this alternative task	2 hours

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2019
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: emotion; amygdala; attention; eye movements
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 2018/113; 2018-A02945-50 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No