Social & Affective Cognition in Alzheimer's Disease & Associated Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorUniversity Hospital, Lille
About this trial
Recent studies have shown that individual neuropsychological scores of patients with Alzheimer's disease and Associated Disorders (ADAD) are only poorly correlated to their behavioral difficulties, such as disinhibition, apathy, social decision-making or vulnerability. Recently, social \& affective cognitive disorders have been highlighted as potential cause of social behavioral abnormalities. However, no previous studies have assessed the specific relationship between social \& affective cognition \& social behavior in ADAD. Our pilot study aims to explore the correlations between core and extended social \& affective cognitive processes and social behavior as observed during the neuropsychological examination, as well as to explore the common brain regions involved in those domains.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men and women;
40 to 85 years of age (included);
Registered with the French Social Security;
Have a study partner. The study partner is required to complete several scales. If the subjects or their study partners are not able to drive, their transport fees will be reimbursed by the promotor.
Disqualifiers
Participants who have contraindications to perform an MRI scan;
Participants with significant sensory deficits that are not corrected by suitable devices.
Participants with dementia caused by a non-neurodegenerative disease, including patients with severe cerebrovascular risk factor load, in the judgment of the investigator;
Participants with other neurodegenerative disease such as Lewy body dementia and Parkinson's disease;
Trial design
Design model
Single group
Treatments tested in this trial
SCANN
Other interventionAdministering 11 tests of social \& affective cognition to each participant as well as 6 scales to their study-partner, in order to have a detailed profile of social \& affective cognitive abilities that we can correlate to an 3DMRI with resting state procedure.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Social & affective cognition assessmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Correlation coefficient between the mini Social cognition & Emotional Assessment - mini-SEA - total score and the Social Behavior Observer Checklist - SBOC - score in all participants.
Time frame
1daySecondary outcomes
1
Correlation coefficients between the mini Social cognition & Emotional Assessment - mini-SEA - sub scores and the neuropsychological assessment (as measured by the Social Behavior Observer Checklist - SBOC - score in all participants.
Time frame
1 day2
Correlation coefficient between the SBOC score with MRI markers in all participants
Time frame
1 day3
Correlation coefficient between mini-SEA sub scores & MRI markers in all participants.
Time frame
1 day4
Correlation coefficients between mini-SEA sub scores with the SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups.
Time frame
1 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
France Alzheimer
Collaborator
Source ClinicalTrials.gov