Alzheimer DiseaseATEMMANCT03971994
Emotion and Attention in Alzheimer's Disease (ATEMMA)
A study testing Facial expression recognition task in people with Alzheimer Disease, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Facial expression recognition task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2019to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attentional Capture by Emotional Information in Alzheimer's Disease : an fMRI Study
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
- Being tested
- Facial expression recognition task
- Keywords
- attention, emotion, eye movements, amygdala
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial expression recognition taskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Young adults | Active comparator | Participants aged between 18 and 40 years old. Receives: Behavioral: Facial expression recognition task |
| Healthy old adults | Active comparator | Participants aged between 65 and 95 years old. Receives: 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. Receives: Behavioral: Facial expression recognition task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classic recognition score
Facial expression recognition score (%)
Measured: 1 hour
Classic fixation time faces
Fixation time on eyes as measured with eyetracking (ms)
Measured: 1 hour
Fixation time scenes
Fixation time on emotional scenes outside of MRI
Measured: 30 mn
Classic fMRI activity
fMRI activity in amygdala and emotional attention networks during face exploration and resting-state
Measured: 2 hours
Secondary outcomes (3)
Alternative recognition score
Facial expression recognition score (%) during an alternative task designed to encourage focus on the eyes
Measured: 1 hour
Alternative fixation time faces
Fixation time on eyes as measured with eyetracking (ms) during this alternative task.
Measured: 1 hour
Alternative fMRI activity
fMRI activity in amygdala and emotional attention networks during this alternative task
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start31 May 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971994
- Sponsor's protocol ID
- 2018/113
- Other IDs
- 2018-A02945-50
- Acronym
- ATEMMA
- Status last verified
- Jan 2022
- First submitted
- 27 May 2019
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attentional Capture by Emotional Information in Alzheimer's Disease : an fMRI Study
- ClinicalTrials.gov ID
- NCT03971994
- Acronym / sponsor ID
- ATEMMA / 2018/113
- Conditions
- Alzheimer Disease
- Keywords
- attention, emotion, eye movements, amygdala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Young adults | Active comparator | Behavioral: Facial expression recognition taskParticipants aged between 18 and 40 years old. |
| Healthy old adults | Active comparator | Behavioral: Facial expression recognition taskParticipants aged between 65 and 95 years old. |
| Patients with Alzheimer's Disease | Experimental | Behavioral: Facial expression recognition taskParticipants aged between 65 and 95 years old with a diagnosis of Alzheimer's Disease. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Healthy volunteers :
- Patients with Alzheimer's Disease :
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial expression recognition taskWe 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. | Behavioural | Healthy old adults, Patients with Alzheimer's Disease, Young adults |
Primary outcome
Classic recognition score
Time frame: 1 hour
Facial expression recognition score (%)
Classic fixation time faces
Time frame: 1 hour
Fixation time on eyes as measured with eyetracking (ms)
Fixation time scenes
Time frame: 30 mn
Fixation time on emotional scenes outside of MRI
Classic fMRI activity
Time frame: 2 hours
fMRI activity in amygdala and emotional attention networks during face exploration and resting-state
3 secondary outcomes
Alternative recognition score
Time frame: 1 hour
Alternative fixation time faces
Time frame: 1 hour
Alternative fMRI activity
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial expression recognition task in people with Alzheimer Disease, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classic recognition score (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.