Alzheimer's DiseaseEMAMNCT04584138
Autobiographical Memory
An observational study of Alzheimer's Disease and Autobiographical Memory, run by Nantes University Hospital at 1 site in France.
Trial summary
This study aims at the assessment of eye movement during autobiographical retrieval (i.e., retrieval of personal memories) in patients with Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Autobiographical Memory, Eye Movement
- What is being tested?
- Study of eye movements
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2021to 25 Nov 2022
- Phase
- Observational
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with Alzheimer's disease in the mild stage
Who may be able to join
- Diagnosis of Alzheimer's Disease at the mild stage
Who cannot join
- Neurological/psychiatric disorders (other than Alzheimer's Disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eye Movement During Autobiographical Memory in Alzheimer's Disease
This study aims at the assessment of eye movement during autobiographical retrieval (i.e., retrieval of personal memories) in patients with Alzheimer's Disease.
Read the detailed description
There is an increased interest in the study of eye movements during the retrieval of autobiographical memories and recent research has demonstrated how retrieval of autobiographical memory can activate eye movement. This research has been however mainly concerned with young adults and, until now, little is known about the relationship between eye movement and autobiographical memory in patients with Alzheimer's Disease. The aim of the current study is therefore to evaluate eye movements during the retrieval of autobiographical memories in patients with Alzheimer's Disease.
- Conditions
- Alzheimer's Disease, Autobiographical Memory, Eye Movement, Memory
- Being tested
- Study of eye movements
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of eye movementsBehavioural
The assessment of eye movement during autobiographical retrieval (i.e., retrieval of personal memories) in patients with Alzheimer's Disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of fixations and saccades
Number
Measured: Four weeks (from assessment till analysis)
Duration of fixations and saccades
Duration in milliseconds
Measured: Four weeks (from assessment till analysis)
Secondary outcomes (1)
Pupil size
In millimeter
Measured: Four weeks (from assessment till analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start15 Apr 2021
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584138
- Sponsor's protocol ID
- RC20_0322
- Acronym
- EMAM
- Status last verified
- Mar 2023
- First submitted
- 23 Sep 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Haj M, M J Janssen S, Gallouj K, Lenoble Q. Autobiographical Memory Increases Pupil Dilation. Transl Neurosci. 2019 Dec 19;10:280-287. doi: 10.1515/tnsci-2019-0044. eCollection 2019.
PubMed 31915538
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Movement During Autobiographical Memory in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04584138
- Acronym / sponsor ID
- EMAM / RC20_0322
- Conditions
- Alzheimer's Disease, Autobiographical Memory, Eye Movement, Memory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 12 Oct 2020 (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.
This study aims at the assessment of eye movement during autobiographical retrieval (i.e., retrieval of personal memories) in patients with Alzheimer's Disease.
Detailed description
There is an increased interest in the study of eye movements during the retrieval of autobiographical memories and recent research has demonstrated how retrieval of autobiographical memory can activate eye movement. This research has been however mainly concerned with young adults and, until now, little is known about the relationship between eye movement and autobiographical memory in patients with Alzheimer's Disease. The aim of the current study is therefore to evaluate eye movements during the retrieval of autobiographical memories in patients with Alzheimer's Disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Alzheimer's disease in the mild stage
Key inclusion criteria (1 listed)
- Diagnosis of Alzheimer's Disease at the mild stage
Key exclusion criteria (1 listed)
- Neurological/psychiatric disorders (other than Alzheimer's Disease)
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 |
|---|---|---|
| Study of eye movementsThe assessment of eye movement during autobiographical retrieval (i.e., retrieval of personal memories) in patients with Alzheimer's Disease. | Behavioural | – |
Primary outcome
Number of fixations and saccades
Time frame: Four weeks (from assessment till analysis)
Number
Duration of fixations and saccades
Time frame: Four weeks (from assessment till analysis)
Duration in milliseconds
1 secondary outcome
Pupil size
Time frame: Four weeks (from assessment till analysis)
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 23 Mar 2023.
- Results publication: PubMed 31915538El Haj M, M J Janssen S, Gallouj K, Lenoble Q. Autobiographical Memory Increases Pupil Dilation. Transl Neurosci. 2019 Dec 19;10:280-287. doi: 10.1515/tnsci-2019-0044. eCollection 2019.
- Autobiographical Memory Increases Pupil DilationLink provided by the sponsor.
- 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?
An observational study of Alzheimer's Disease and Autobiographical Memory, run by Nantes University Hospital 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 1 inclusion and 1 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 23 Mar 2023. 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?
Number of fixations and saccades (time frame: Four weeks (from assessment till analysis)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584138, which also lists 1 linked publication.
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 23 Mar 2023.