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NCT Number: NCT06338397

Social & Affective Cognition 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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

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.

    Time frame: 1day

Secondary outcomes

  1. 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.

    Time frame: 1 day

  2. Correlation coefficient between the SBOC score with MRI markers in all participants

    Time frame: 1 day

  3. Correlation coefficient between mini-SEA sub scores & MRI markers in all participants.

    Time frame: 1 day

  4. Correlation coefficients between mini-SEA sub scores with the SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups.

    Time frame: 1 day

  5. Correlation coefficients between SCANN sub-scores and the SBOC, SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups.

    Time frame: 1 day

Study contacts

Contact information is provided by the study sponsor or research team.

Thibaud LEBOUVIER, MD, PhD

CONTACT

[email protected]

3.20.44.60.21 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • France Alzheimer

Registry information

Official study title

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

Acronym: SOCIALIZE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 29, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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