Emotion and Attention in Alzheimer's Disease (ATEMMA)

Alzheimer Disease Clinical Trial

— ATEMMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03971994
• Other study ID #: 2018/113
• Secondary ID: 2018-A02945-50
• Status: Completed
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: January 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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.

Locations

Country	Name	City	State
France	Grenoble University Hospital	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Classic recognition score	Facial expression recognition score (%)	1 hour
Primary	Classic fixation time faces	Fixation time on eyes as measured with eyetracking (ms)	1 hour
Primary	Fixation time scenes	Fixation time on emotional scenes outside of MRI	30 mn
Primary	Classic fMRI activity	fMRI activity in amygdala and emotional attention networks during face exploration and resting-state	2 hours
Secondary	Alternative recognition score	Facial expression recognition score (%) during an alternative task designed to encourage focus on the eyes	1 hour
Secondary	Alternative fixation time faces	Fixation time on eyes as measured with eyetracking (ms) during this alternative task.	1 hour
Secondary	Alternative fMRI activity	fMRI activity in amygdala and emotional attention networks during this alternative task	2 hours