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Recruiting NCT06338397

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

No phase Interventional Alzheimer's Disease Frontotemporal Degeneration (Semantic & Behavioral Variants)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SCANN.
Who it may be relevant to
Registry conditions: Alzheimer's Disease, Frontotemporal Degeneration (Semantic & Behavioral Variants). Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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 outcome measures (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. [Time frame: 1 day]
  • Correlation coefficient between the SBOC score with MRI markers in all participants [Time frame: 1 day]
  • Correlation coefficient between mini-SEA sub scores & MRI markers in all participants. [Time frame: 1 day]
  • 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]
  • 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]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Lille University Hospital — Lille

Identifiers

NCT: NCT06338397 · 2023_0455

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗