Emotion and Attention in Alzheimer's Disease (ATEMMA)

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT03971994
Collaborator
(none)
41
1
3
30
1.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Facial expression recognition task
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Attentional Capture by Emotional Information in Alzheimer's Disease : an fMRI Study
Actual Study Start Date :
May 31, 2019
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Classic recognition score [1 hour]

    Facial expression recognition score (%)

  2. Classic fixation time faces [1 hour]

    Fixation time on eyes as measured with eyetracking (ms)

  3. Fixation time scenes [30 mn]

    Fixation time on emotional scenes outside of MRI

  4. Classic fMRI activity [2 hours]

    fMRI activity in amygdala and emotional attention networks during face exploration and resting-state

Secondary Outcome Measures

  1. Alternative recognition score [1 hour]

    Facial expression recognition score (%) during an alternative task designed to encourage focus on the eyes

  2. Alternative fixation time faces [1 hour]

    Fixation time on eyes as measured with eyetracking (ms) during this alternative task.

  3. Alternative fMRI activity [2 hours]

    fMRI activity in amygdala and emotional attention networks during this alternative task

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Grenoble University Hospital La Tronche France

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT03971994
Other Study ID Numbers:
  • 2018/113
  • 2018-A02945-50
First Posted:
Jun 3, 2019
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Grenoble
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2022