Clinical trial NCT03971994: Emotion and Attention in Alzheimer's Disease (ATEMMA)
Official title: Attentional Capture by Emotional Information in Alzheimer's Disease : an fMRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: attention
emotion
eye movements
amygdala
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Classic recognition score
timeFrame: 1 hour
measure: Classic fixation time faces
timeFrame: 1 hour
measure: Fixation time scenes
timeFrame: 30 mn
measure: Classic fMRI activity
timeFrame: 2 hours
Secondary outcomes:
measure: Alternative recognition score
timeFrame: 1 hour
measure: Alternative fixation time faces
timeFrame: 1 hour
measure: Alternative fMRI activity
timeFrame: 2 hours
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Grenoble University Hospital
Study officials:
References: