NCT05800028

Brief 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. 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Mar 2023Dec 2026

Study Start

First participant enrolled

March 10, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 20, 2024

Status Verified

August 1, 2024

Enrollment Period

3.8 years

First QC Date

March 23, 2023

Last Update Submit

September 19, 2024

Conditions

Keywords

MemorySocial InteractionPersonalityAlzheimer DiseaseAphasia, Primary Progressive

Outcome Measures

Primary Outcomes (1)

  • 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

    2 days

Study Arms (4)

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.

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.

Behavioral: Learning new information

HC group

46 individuals without cognitive complain.

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.

Behavioral: Learning new information

Interventions

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 groupHC groupPartnersSPPA group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

AD group SPPA group HC group Partners

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, 14000, France

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alzheimer DiseaseFrontotemporal DementiaAphasia, Primary Progressive

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersFrontotemporal Lobar DegenerationTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesAphasiaSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Olivier MARTINAUD, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 5, 2023

Study Start

March 10, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations