search
Back to results

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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Facial expression recognition task
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alzheimer Disease focused on measuring attention, emotion, eye movements, amygdala

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Grenoble University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Young adults

Healthy old adults

Patients with Alzheimer's Disease

Arm Description

Participants aged between 18 and 40 years old.

Participants aged between 65 and 95 years old.

Participants aged between 65 and 95 years old with a diagnosis of Alzheimer's Disease.

Outcomes

Primary Outcome Measures

Classic recognition score
Facial expression recognition score (%)
Classic fixation time faces
Fixation time on eyes as measured with eyetracking (ms)
Fixation time scenes
Fixation time on emotional scenes outside of MRI
Classic fMRI activity
fMRI activity in amygdala and emotional attention networks during face exploration and resting-state

Secondary Outcome Measures

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

Full Information

First Posted
May 27, 2019
Last Updated
January 14, 2022
Sponsor
University Hospital, Grenoble
search

1. Study Identification

Unique Protocol Identification Number
NCT03971994
Brief Title
Emotion and Attention in Alzheimer's Disease (ATEMMA)
Acronym
ATEMMA
Official Title
Attentional Capture by Emotional Information in Alzheimer's Disease : an fMRI Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
attention, emotion, eye movements, amygdala

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Young adults
Arm Type
Active Comparator
Arm Description
Participants aged between 18 and 40 years old.
Arm Title
Healthy old adults
Arm Type
Active Comparator
Arm Description
Participants aged between 65 and 95 years old.
Arm Title
Patients with Alzheimer's Disease
Arm Type
Experimental
Arm Description
Participants aged between 65 and 95 years old with a diagnosis of Alzheimer's Disease.
Intervention Type
Behavioral
Intervention Name(s)
Facial expression recognition task
Intervention Description
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.
Primary Outcome Measure Information:
Title
Classic recognition score
Description
Facial expression recognition score (%)
Time Frame
1 hour
Title
Classic fixation time faces
Description
Fixation time on eyes as measured with eyetracking (ms)
Time Frame
1 hour
Title
Fixation time scenes
Description
Fixation time on emotional scenes outside of MRI
Time Frame
30 mn
Title
Classic fMRI activity
Description
fMRI activity in amygdala and emotional attention networks during face exploration and resting-state
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Alternative recognition score
Description
Facial expression recognition score (%) during an alternative task designed to encourage focus on the eyes
Time Frame
1 hour
Title
Alternative fixation time faces
Description
Fixation time on eyes as measured with eyetracking (ms) during this alternative task.
Time Frame
1 hour
Title
Alternative fMRI activity
Description
fMRI activity in amygdala and emotional attention networks during this alternative task
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Grenoble University Hospital
City
La Tronche
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Emotion and Attention in Alzheimer's Disease (ATEMMA)

We'll reach out to this number within 24 hrs