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

NCT06338397 | Recruiting

• 1 other identifier: 2023_0455
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease; Frontotemporal Degeneration (Semantic & Behavioral Variants)

Keywords

Emotions; social cognition; social semantics; neuropsychology; frontotemporal dementia

Outcome Measures

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.

  1day

Secondary Outcomes (5)

• 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

Study Arms (1)

Social & affective cognition assessment

EXPERIMENTAL

Other: SCANN

Interventions

SCANN OTHER

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.

Social & affective cognition assessment

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women;
• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Hospital, Lille: lead
• France Alzheimer: collaborator

Study Sites (1)

Lille University Hospital

Lille, 59000, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Frontotemporal Dementia

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Thibaud LEBOUVIER, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thibaud LEBOUVIER, MD, PhD

CONTACT

3.20.44.60.21; Thibaud.LEBOUVIER@chu-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: January 28, 2025
• Primary Completion (Estimated): January 28, 2028
• Study Completion (Estimated): May 2, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)