Social & Affective Cognition in Alzheimer's Disease & Associated Disorders (SOCIALIZE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer's Disease; Frontotemporal Degeneration (Semantic & Behavioral Variants)
• Intervention / Treatment: Other: SCANN

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thibaud LEBOUVIER, MD, PhD; Phone Number: +33 3.20.44.60.21; Email: Thibaud.LEBOUVIER@chu-lille.fr

Study Locations

• France
  • Lille, France, 59000
    • Recruiting
    • Lille University Hospital
    • Contact: DRI; Phone Number: +33 3.20.44.41.45; Email: drs.promotion@chu-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social & affective cognition assessment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 coefficient between mini-SEA sub scores & 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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: France Alzheimer
• Investigators: Principal Investigator: Thibaud LEBOUVIER, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2025
• Primary Completion (Estimated): January 28, 2028
• Study Completion (Estimated): May 2, 2028

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: social cognition; Emotions; neuropsychology; frontotemporal dementia; social semantics
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Metabolic Diseases; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Frontotemporal Lobar Degeneration; Nutritional and Metabolic Diseases; Alzheimer Disease; Frontotemporal Dementia
• Other Study ID Numbers: 2023_0455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No