Emotion and Attention in Alzheimer's Disease (ATEMMA)

NCT03971994 | Completed

• 2 other identifiers: 2018/1132018-A02945-50
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Keywords

attention; emotion; eye movements; amygdala

Outcome Measures

Primary Outcomes (4)

• Classic recognition score

  Facial expression recognition score (%)

  1 hour

• Classic fixation time faces

  Fixation time on eyes as measured with eyetracking (ms)

  1 hour

• Fixation time scenes

  Fixation time on emotional scenes outside of MRI

  30 mn

• Classic fMRI activity

  fMRI activity in amygdala and emotional attention networks during face exploration and resting-state

  2 hours

Secondary Outcomes (3)

• Alternative recognition score

  1 hour

• Alternative fixation time faces

  1 hour

• Alternative fMRI activity

  2 hours

Study Arms (3)

Young adults

ACTIVE COMPARATOR

Participants aged between 18 and 40 years old.

Behavioral: Facial expression recognition task

Healthy old adults

ACTIVE COMPARATOR

Participants aged between 65 and 95 years old.

Behavioral: Facial expression recognition task

Patients with Alzheimer's Disease

EXPERIMENTAL

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

Behavioral: Facial expression recognition task

Interventions

Facial expression recognition task 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; Patients with Alzheimer's Disease; Young adults

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

La Tronche, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 3, 2019
• Study Start: May 31, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)