Clinical trial NCT06338397: Social & Affective Cognition in Alzheimer's Disease & Associated Disorders
Official title: Social & Affective Cognition as Determinant of Social Behavior in Alzheimer's Disease & Associated Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer's Disease
Frontotemporal Degeneration (Semantic & Behavioral Variants)
Keywords: Emotions
social cognition
social semantics
neuropsychology
frontotemporal dementia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: France Alzheimer
First posted: 2024-03-29
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: Inclusion Criteria:

* 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.
* Fluent in French, able to read and write;

Exclusion Criteria:

* 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;
* Participants with other serious neurological disorder such as brain tumor, stroke, epilepsy, hydrocephalus and any condition which contraindicates, in the investigator's judgment, entry to the study;
* Participants with excessive alcohol intake or drug abuse, in the judgment of the investigator;
* Participants who, in the opinion of the investigator, have a risk of non-compliance to the study procedures;

Primary outcomes:
measure: Correlation coefficient between the mini Social cognition & Emotional Assessment - mini-SEA - total score and the Social Behavior Observer Checklist - SBOC - score in all participants.
timeFrame: 1day
Secondary outcomes:
measure: 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.
timeFrame: 1 day
measure: Correlation coefficient between the SBOC score with MRI markers in all participants
timeFrame: 1 day
measure: Correlation coefficient between mini-SEA sub scores & MRI markers in all participants.
timeFrame: 1 day
measure: Correlation coefficients between mini-SEA sub scores with the SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups.
timeFrame: 1 day
measure: Correlation coefficients between SCANN sub-scores and the SBOC, SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups.
timeFrame: 1 day
Other outcomes:
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