Alzheimer DiseaseMEM&SONCT05800028
Memory and Social Interactions
An observational study of Alzheimer Disease and Semantic Dementia, run by University Hospital, Caen at 1 site in France.
Trial summary
Memory and social interaction are intimately linked. On the one hand, social interaction is a privileged context for learning, and on the other hand, appropriate social interactions involve remembering the partners encountered and previous exchanges. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Semantic Dementia
- What is being tested?
- Learning new information
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 192 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: AD group SPPA group HC group Partners
Who may be able to join
- AD group: Age between 50 and 85 years, Diagnosis of probable Alzheimer's disease dementia with amnestic presentation and documented decline following the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease.
- SPPA group: Age between 50 and 85 years, Diagnosis of the semantic variant of primary progressive aphasia following the classification of primary progressive aphasia and its variants.
- HC group: Age between 50 and 85 years, Matched in age and sociocultural status with one of the AD or SPPA patients, No cognitive complain, No recent reduction in social or cognitive activities, No contraindication to MRI examination.
- Partners: Age over 18 years of age , No cognitive complaints, Social interactions of at least two hours per week for at least 5 years with one of the individuals of the other three groups.
Who cannot join
- Deprivation of liberty by judicial or administrative decision
- Not being a member of a social security system
- Concurrent participation in a therapeutic drug trial
- Uncorrected visual and/or auditory disorders that are sufficiently significant to interfere with the protocol
- History of neurological disorders (stroke, epilepsy, head trauma with loss of consciousness for more than one hour)
- History of chronic alcoholism or drug abuse
Show all 9Show fewer
- History within the last 10 years of a clinically significant major psychiatric disorder
- Cancer within the past 5 years, except for squamous cell carcinoma
- Use of medications that may affect cognitive and/or brain function. Given the number of molecules involved and the dosages, the principal investigator will judge on a case-by-case basis whether regular use of certain medications will interfere with the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14000
Olivier Martinaud, MD, PhD, 33 2 31 06 46 17, martinaud-o@chu-caen.fr
Mickaël Laisney, PhD, 33 2 31 56 83 93, mickael.laisney@ephe.sorbonne.fr
About this study
Official title: Memory and Social Interactions: Study in Alzheimer's Disease and Semantic Progressive Aphasia
Memory and social interaction are intimately linked. On the one hand, social interaction is a privileged context for learning, and on the other hand, appropriate social interactions involve remembering the partners encountered and previous exchanges. People with Alzheimer's disease classic syndrome variant (AD) have a major impairment of episodic memory, while people with the semantic variant of primary progressive aphasia (SPPA) are characterized by semantic disorders in the foreground, associated with changes in their social behavior with a tendency to egocentricity. In both cases, patients frequently have reduced social interactions. Although social interaction situations seem to constitute a privileged learning context, their effectiveness for patients with cognitive disorders must be evaluated and the conditions under which they are effective must be established. The main objective of this study is to determine whether social interaction constitutes a beneficial context for learning new information and whether the presence of social behavior disorders alters this benefit. More broadly, the goal is to better understand the mechanisms underlying the possible beneficial effect of learning in social contexts and to clarify the links between memory performance in different social contexts, cognitive disorders, social behavioral changes and personality traits. Finally, a description will be made of the brain substrates associated with memory performance obtained during learning in social contexts in order to investigate their particularities. Thirty couples each including a person with AD, 16 couples each including a person with SPPA and 46 couples of persons without cognitive complaints (HC), one of which will be matched in gender and age to one of the patients, will be included in the study. Participants will perform image location learning in a grid, in three social contexts in which both members of the couple are involved: 1) simple presence of others, 2) by observation and 3) in collaboration. A psychometric assessment including social cognition and classical tests assessing memory, and questionnaires concerning global executive functioning, social behavior and personality will be offered to all participants. Patients in the AD and SPPA groups and the matched individual in the HC group will undergo anatomical and functional brain magnetic resonance imaging (MRI).
- Conditions
- Alzheimer Disease, Semantic Dementia
- Being tested
- Learning new information
- Keywords
- Memory, Social Interaction, Personality, Alzheimer Disease, Aphasia, Primary Progressive
- Medical subject headings
- Alzheimer Disease, Frontotemporal Dementia, Aphasia, Primary Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning new informationBehavioural
The purpose of this study is to test the effects of different social contexts when learning new information. Participants in the AD, SPPA, and HC experimental groups will be given tests to learn verbal information (location of drawings in a grid). The learning phases of these tests are presented in the form of a memory game in which participants are asked to make pairs of drawings by finding the second copy of the proposed pair by trial and error in a grid. After learning, a task of recognizing the position of the drawings in the grid is performed. Each participant will carry out this learning in three different conditions: 1) learning alone, 2) learning by observation of the reconstruction of the pairs of images by a partner, and 3) collaborative learning in which the two game partners discover and reconstruct the pairs together.
| Study group | Role | What they receive |
|---|---|---|
| AD group | 30 individuals aged between 50 and 85 years with probable Alzheimer's disease dementia with amnestic presentation and documented decline following the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Receives: Behavioral: Learning new information | |
| SPPA group | 16 individuals aged between 50 and 85 years with the semantic variant of primary progressive aphasia following the classification of primary progressive aphasia and its variants. Receives: Behavioral: Learning new information | |
| HC group | 46 individuals without cognitive complain. Receives: Behavioral: Learning new information | |
| Partners | 92 individuals without cognitive complaints. Each of these individuals will partner with one of the members of the experimental groups to carry out learning in social contexts. Receives: Behavioral: Learning new information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Memory Test
Memory scores (from 0 to 10) on an experimental test (higher score means a better performance) in 3 different contexts of learning
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start10 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen, Rennes University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800028
- Sponsor's protocol ID
- 2022-A00198-35
- Acronym
- MEM&SO
- Status last verified
- Aug 2024
- First submitted
- 23 Mar 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saliou P, Chavant J, Belliard S, Merck C, de La Sayette V, Wallon D, Martinaud O, Eustache F, Laisney M. MEM&SO protocol: understanding the determinants of social learning in neurodegenerative diseases. BMC Psychol. 2024 May 28;12(1):307. doi: 10.1186/s40359-024-01791-w.
PubMed 38807183
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory and Social Interactions: Study in Alzheimer's Disease and Semantic Progressive Aphasia
- ClinicalTrials.gov ID
- NCT05800028
- Acronym / sponsor ID
- MEM&SO / 2022-A00198-35
- Conditions
- Alzheimer Disease, Semantic Dementia
- Keywords
- Memory, Social Interaction, Personality, Alzheimer Disease, Aphasia, Primary Progressive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- University Hospital, Rouen, Rennes University Hospital
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Apr 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.
Memory and social interaction are intimately linked. On the one hand, social interaction is a privileged context for learning, and on the other hand, appropriate social interactions involve remembering the partners encountered and previous exchanges. People with Alzheimer's disease classic syndrome variant (AD) have a major impairment of episodic memory, while people with the semantic variant of primary progressive aphasia (SPPA) are characterized by semantic disorders in the foreground, associated with changes in their social behavior with a tendency to egocentricity. In both cases, patients frequently have reduced social interactions. Although social interaction situations seem to constitute a privileged learning context, their effectiveness for patients with cognitive disorders must be evaluated and the conditions under which they are effective must be established. The main objective of this study is to determine whether social interaction constitutes a beneficial context for learning new information and whether the presence of social behavior disorders alters this benefit. More broadly, the goal is to better understand the mechanisms underlying the possible beneficial effect of learning in social contexts and to clarify the links between memory performance in different social contexts, cognitive disorders, social behavioral changes and personality traits. Finally, a description will be made of the brain substrates associated with memory performance obtained during learning in social contexts in order to investigate their particularities. Thirty couples each including a person with AD, 16 couples each including a person with SPPA and 46 couples of persons without cognitive complaints (HC), one of which will be matched in gender and age to one of the patients, will be included in the study. Participants will perform image location learning in a grid, in three social contexts in which both members of the couple are involved: 1) simple presence of others, 2) by observation and 3) in collaboration. A psychometric assessment including social cognition and classical tests assessing memory, and questionnaires concerning global executive functioning, social behavior and personality will be offered to all participants. Patients in the AD and SPPA groups and the matched individual in the HC group will undergo anatomical and functional brain magnetic resonance imaging (MRI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AD group | – | Behavioral: Learning new information30 individuals aged between 50 and 85 years with probable Alzheimer's disease dementia with amnestic presentation and documented decline following the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. |
| SPPA group | – | Behavioral: Learning new information16 individuals aged between 50 and 85 years with the semantic variant of primary progressive aphasia following the classification of primary progressive aphasia and its variants. |
| HC group | – | Behavioral: Learning new information46 individuals without cognitive complain. |
| Partners | – | Behavioral: Learning new information92 individuals without cognitive complaints. Each of these individuals will partner with one of the members of the experimental groups to carry out learning in social contexts. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- AD group SPPA group HC group Partners
Key inclusion criteria (4 listed)
- AD group: Age between 50 and 85 years, Diagnosis of probable Alzheimer's disease dementia with amnestic presentation and documented decline following the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease.
- SPPA group: Age between 50 and 85 years, Diagnosis of the semantic variant of primary progressive aphasia following the classification of primary progressive aphasia and its variants.
- HC group: Age between 50 and 85 years, Matched in age and sociocultural status with one of the AD or SPPA patients, No cognitive complain, No recent reduction in social or cognitive activities, No contraindication to MRI examination.
- Partners: Age over 18 years of age , No cognitive complaints, Social interactions of at least two hours per week for at least 5 years with one of the individuals of the other three groups.
Key exclusion criteria (9 listed)
- Deprivation of liberty by judicial or administrative decision
- Not being a member of a social security system
- Concurrent participation in a therapeutic drug trial
- Uncorrected visual and/or auditory disorders that are sufficiently significant to interfere with the protocol
- History of neurological disorders (stroke, epilepsy, head trauma with loss of consciousness for more than one hour)
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 |
|---|---|---|
| Learning new informationThe purpose of this study is to test the effects of different social contexts when learning new information. Participants in the AD, SPPA, and HC experimental groups will be given tests to learn verbal information (location of drawings in a grid). The learning phases of these tests are presented in the form of a memory game in which participants are asked to make pairs of drawings by finding the second copy of the proposed pair by trial and error in a grid. After learning, a task of recognizing the position of the drawings in the grid is performed. Each participant will carry out this learning in three different conditions: 1) learning alone, 2) learning by observation of the reconstruction of the pairs of images by a partner, and 3) collaborative learning in which the two game partners discover and reconstruct the pairs together. | Behavioural | AD group, HC group, Partners, SPPA group |
Primary outcome
Social Memory Test
Time frame: 2 days
Memory scores (from 0 to 10) on an experimental test (higher score means a better performance) in 3 different contexts of learning
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Derived from this study: PubMed 38807183Saliou P, Chavant J, Belliard S, Merck C, de La Sayette V, Wallon D, Martinaud O, Eustache F, Laisney M. MEM&SO protocol: understanding the determinants of social learning in neurodegenerative diseases. BMC Psychol. 2024 May 28;12(1):307. doi: 10.1186/s40359-024-01791-w.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Active, not recruiting
Promoting Physical Activity in Older Hispanic/Latino(a) Adults
Sedentary Behavior, Physical Inactivity
RecruitingPhase 2
Alzheimer's Tau Platform: Master Protocol
Preclinical Alzheimer's Disease, Alzheimer Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Enrolling by invitationPhase 2
Alzheimer's Tau Platform: Regimen A - AADvac1
Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease
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.
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 Disease and Semantic Dementia, run by University Hospital, Caen 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 20 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier MARTINAUD, MD, PhD (33 2 31 06 46 17, martinaud-o@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Memory Test (time frame: 2 days). 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 NCT05800028, 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 20 Sep 2024; AzTrials last refreshed its copy on 27 Oct 2026.