Skip to main content
Clinical Trials/NCT06338397
NCT06338397
Not Yet Recruiting
N/A

Social & Affective Cognition as Determinant of Social Behavior in Alzheimer's Disease & Associated Disorders

University Hospital, Lille0 sites120 target enrollmentMay 2, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
University Hospital, Lille
Enrollment
120
Primary Endpoint
Correlation coefficient between the mini Social cognition & Emotional Assessment - mini-SEA - total score and the Social Behavior Observer Checklist - SBOC - score in all participants.
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2, 2024
End Date
May 2, 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

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;

Outcomes

Primary Outcomes

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: 1day

Secondary Outcomes

  • 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.(1 day)
  • Correlation coefficient between the SBOC score with MRI markers in all participants(1 day)
  • Correlation coefficients between mini-SEA sub scores with the SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups.(1 day)
  • Correlation coefficients between SCANN sub-scores and the SBOC, SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups.(1 day)
  • Correlation coefficient between mini-SEA sub scores & MRI markers in all participants.(1 day)

Similar Trials