- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05800028
Memory and Social Interactions (MEM&SO)
April 26, 2023 updated by: University Hospital, Caen
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
192
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Olivier Martinaud, MD, PhD
- Phone Number: 33 2 31 06 46 17
- Email: martinaud-o@chu-caen.fr
Study Contact Backup
- Name: Mickaël Laisney, PhD
- Phone Number: 33 2 31 56 83 93
- Email: mickael.laisney@ephe.sorbonne.fr
Study Locations
-
-
-
Caen, France, 14000
- Recruiting
- CAEN University Hospital
-
Contact:
- Olivier Martinaud, MD, PhD
- Phone Number: 33 2 31 06 46 17
- Email: martinaud-o@chu-caen.fr
-
Contact:
- Mickaël Laisney, PhD
- Phone Number: 33 2 31 56 83 93
- Email: mickael.laisney@ephe.sorbonne.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
AD group SPPA group HC group Partners
Description
Inclusion criteria:
- 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.
Exclusion criteria (for all groups):
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HC group
46 individuals without cognitive complain.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2023
Primary Completion (Anticipated)
December 31, 2026
Study Completion (Anticipated)
December 31, 2026
Study Registration Dates
First Submitted
March 23, 2023
First Submitted That Met QC Criteria
March 23, 2023
First Posted (Actual)
April 5, 2023
Study Record Updates
Last Update Posted (Actual)
April 27, 2023
Last Update Submitted That Met QC Criteria
April 26, 2023
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Dementia
- Tauopathies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Alzheimer Disease
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID Numbers
- 2022-A00198-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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