Alzheimer DiseaseADAENCT06105047
Validation of a Remediation Method for Memory Disorders Using Motor and Emotional Encoding in Patients With Alzheimer's Disease
A study testing Cognitive tests in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
Memories are more robust when they are multitraced. This means that the more a piece of information is mediated by different sensory inputs, the more resistant it is to being forgotten. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Cognitive tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Jan 2024to 16 May 2025
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Alzheimer's disease by one of the consulting physicians, neurologist and/or geriatrician of whom the patient has been informed.
- Early stage (MMSE ≥ 22)
- Neuropsychological assessment within 6 months of inclusion.
- Affiliation with a social security scheme
- Age equal to or greater than 60
- French mother tongue
- Agreement to participate / signature of consent form
Who cannot join
- Uncorrected perceptual disorders
- Other neurological or psychiatric history
- Inability to communicate
- Delusional or psychotic state
- Person unable to give informed consent
- Refusal to participate
- Participation in a study on a drug/medical device/care technique likely to affect cognitive functions
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Grenoble
Grenoble
CHU de Saint-Etienne
Saint-Etienne, 42055
HCL
Villeurbanne
About this study
Official title: Validation of a Remediation Method for Memory Disorders Using Motor and Emotional Encoding in Patients With Alzheimer's Disease (AD)
Memories are more robust when they are multitraced. This means that the more a piece of information is mediated by different sensory inputs, the more resistant it is to being forgotten. Many works in the field of embodied cognition show that new learnings are better recalled over the long term when they are learned during body mobilization. Other works show that musical stimulation could be a good way of eliciting physiological and emotional states more favorable to the memorization of new contents. However, to date, no studies have examined the positive effects of these two tools combined in Alzheimer's disease. The investigators suggest that it is possible to optimize memory in Alzheimer's disease by referring to their motor and emotional resources. The hypothesis is that information will be better recalled with multimodal enriched learning.
Read the detailed description
In a within subjects design, all patients take part in four conditions. In each condition, sentences describing actions will be displayed. In a control condition, they will be asked to read the sentence aloud; in a motor-only condition, they will also be asked to mime the sentence; in an emotional-only condition, they will be asked to read the sentence while listening to music; and in a dual condition, they will be asked to both mime and listen to music. Immediately after each condition, they will realize a recognition task. The main criterion used in our statistical analyses will be the discrimination threshold.
- Conditions
- Alzheimer Disease
- Being tested
- Cognitive tests
- Keywords
- Alzheimer, Action memory, Musical memory
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive testsBehavioural
. Patients will perform experimental task in four conditions : control, mime, emotion, dual In a control condition : they will be asked to read the sentence aloud; in a motor-only condition, they will also be asked to mime the sentence; in an emotional-only condition, they will be asked to read the sentence while listening to music; in a dual condition, they will be asked to both mime and listen to music. Immediately after each condition, they will realize a recognition task
- quiz : Geneva Music Induced Checklist, GMIAC, Coutinho \& Scherer, 2017
| Study group | Role | What they receive |
|---|---|---|
| Patients with Alzheimer disease | Experimental | Patients will perform experimental task in four conditions : control, mime, emotion, dual Receives: Behavioral: Cognitive tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Discrimination score"
Comparison of the recognition score obtained in each of the experimental conditions to the recognition score obtained in the control condition The score = the Number of correct answer (0 to 15, the higher score means better outcome)
Measured: Weeks: 2
Secondary outcomes (1)
"Geneva Music-Induced Affect Checklist" scale
Analysis Geneva Music-Induced Affect Checklist scale results. It is composed of 4 sub-score dimensions such as valence, activation, tension (stress level) and pleasure (14 items scale 1: "not at all" to 5 "hugely, it's a qualitative scale)
Measured: Weeks: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start22 Jan 2024
- Primary completion9 May 2025
- Study completion16 May 2025
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.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline BORG, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105047
- Sponsor's protocol ID
- 23CH154
- Other IDs
- ANSM
- Acronym
- ADAE
- Status last verified
- Jun 2025
- First submitted
- 23 Oct 2023
- Last updated
- 25 Jun 2025
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Remediation Method for Memory Disorders Using Motor and Emotional Encoding in Patients With Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT06105047
- Acronym / sponsor ID
- ADAE / 23CH154
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer, Action memory, Musical memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 27 Oct 2023 (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.
Memories are more robust when they are multitraced. This means that the more a piece of information is mediated by different sensory inputs, the more resistant it is to being forgotten. Many works in the field of embodied cognition show that new learnings are better recalled over the long term when they are learned during body mobilization. Other works show that musical stimulation could be a good way of eliciting physiological and emotional states more favorable to the memorization of new contents. However, to date, no studies have examined the positive effects of these two tools combined in Alzheimer's disease. The investigators suggest that it is possible to optimize memory in Alzheimer's disease by referring to their motor and emotional resources. The hypothesis is that information will be better recalled with multimodal enriched learning.
Detailed description
In a within subjects design, all patients take part in four conditions. In each condition, sentences describing actions will be displayed. In a control condition, they will be asked to read the sentence aloud; in a motor-only condition, they will also be asked to mime the sentence; in an emotional-only condition, they will be asked to read the sentence while listening to music; and in a dual condition, they will be asked to both mime and listen to music. Immediately after each condition, they will realize a recognition task. The main criterion used in our statistical analyses will be the discrimination threshold.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Alzheimer disease | Experimental | Behavioral: Cognitive testsPatients will perform experimental task in four conditions : control, mime, emotion, dual |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Alzheimer's disease by one of the consulting physicians, neurologist and/or geriatrician of whom the patient has been informed.
- Early stage (MMSE ≥ 22)
- Neuropsychological assessment within 6 months of inclusion.
- Affiliation with a social security scheme
- Age equal to or greater than 60
Key exclusion criteria (7 listed)
- Uncorrected perceptual disorders
- Other neurological or psychiatric history
- Inability to communicate
- Delusional or psychotic state
- Person unable to give informed consent
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 |
|---|---|---|
| Cognitive tests. Patients will perform experimental task in four conditions : control, mime, emotion, dual In a control condition : they will be asked to read the sentence aloud; in a motor-only condition, they will also be asked to mime the sentence; in an emotional-only condition, they will be asked to read the sentence while listening to music; in a dual condition, they will be asked to both mime and listen to music. Immediately after each condition, they will realize a recognition task * quiz : Geneva Music Induced Checklist, GMIAC, Coutinho \& Scherer, 2017 | Behavioural | Patients with Alzheimer disease |
Primary outcome
"Discrimination score"
Time frame: Weeks: 2
Comparison of the recognition score obtained in each of the experimental conditions to the recognition score obtained in the control condition The score = the Number of correct answer (0 to 15, the higher score means better outcome)
1 secondary outcome
"Geneva Music-Induced Affect Checklist" scale
Time frame: Weeks: 2
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 25 Jun 2025.
- 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.
Céline BORG, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive tests in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites 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 7 inclusion and 7 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 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
"Discrimination score" (time frame: Weeks: 2). 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 25 Jun 2025; AzTrials last refreshed its copy on 29 Oct 2026.