| NCT ID | NCT05800028 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Caen |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 192 participants |
| Start Date | 2023-03-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 192 participants in total. It began in 2023-03-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05800028 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05800028 currently recruiting?
Yes, NCT05800028 is actively recruiting participants. Contact the research team at martinaud-o@chu-caen.fr for enrollment information.
Where is the NCT05800028 trial being conducted?
This trial is being conducted at Caen, France.
Who is sponsoring the NCT05800028 clinical trial?
NCT05800028 is sponsored by University Hospital, Caen. The trial plans to enroll 192 participants.
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