Emotion and Attention in Alzheimer's Disease (ATEMMA)

Not Applicable

Completed

• Conditions: Alzheimer Disease
• Interventions: Behavioral: Facial expression recognition task

• Registration Number: NCT03971994
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-27
• Study Start: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy old adults	Facial expression recognition task	Participants aged between 65 and 95 years old.
Patients with Alzheimer's Disease	Facial expression recognition task	Participants aged between 65 and 95 years old with a diagnosis of Alzheimer's Disease.
Young adults	Facial expression recognition task	Participants aged between 18 and 40 years old.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 La Tronche, France