Emotion and Attention in Alzheimer's Disease (ATEMMA)

NCT ID: NCT03971994

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2021-11-30

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Young adults

Participants aged between 18 and 40 years old.

Group Type: ACTIVE_COMPARATOR

Facial expression recognition task

Intervention Type: BEHAVIORAL

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.

Healthy old adults

Participants aged between 65 and 95 years old.

Group Type: ACTIVE_COMPARATOR

Facial expression recognition task

Intervention Type: BEHAVIORAL

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.

Patients with Alzheimer's Disease

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

Group Type: EXPERIMENTAL

Facial expression recognition task

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Grenoble University Hospital

La Tronche, , France

Countries

France

Other Identifiers

2018-A02945-50

Identifier Type: OTHER

Identifier Source: secondary_id

2018/113

Identifier Type: -

Identifier Source: org_study_id