Social & Affective Cognition in Alzheimer's Disease & Associated Disorders

Alzheimer's Disease Clinical Trial

— SOCIALIZE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06338397
• Other study ID #: 2023_0455
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: May 2, 2027

Study information

• Verified date: March 2024
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 2, 2027
• Est. primary completion date: May 2, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Other:
• SCANN
Administering 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	France Alzheimer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation coefficient between the mini Social cognition & Emotional Assessment - mini-SEA - total score and the Social Behavior Observer Checklist - SBOC - score in all participants.		1day
Secondary	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
Secondary	Correlation coefficient between the SBOC score with MRI markers in all participants		1 day
Secondary	Correlation coefficient between mini-SEA sub scores & MRI markers in all participants.		1 day
Secondary	Correlation coefficients between mini-SEA sub scores with the SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups.		1 day
Secondary	Correlation coefficients between SCANN sub-scores and the SBOC, SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups.		1 day