Social and emotional thinking in Alzheimer's disease and related disorders
Social & Affective Cognition as Determinant of Social Behavior in Alzheimer's Disease & Associated Disorders
It will test whether social and emotional thinking skills relate to social behavior and brain changes in people aged 40–85 with Alzheimer's disease or the semantic or behavioral variants of frontotemporal degeneration.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT06338397 on ClinicalTrials.gov |
What this trial studies
This pilot will enroll people with Alzheimer's disease and the semantic or behavioral variants of frontotemporal degeneration and their study partners. Participants will complete a battery of neuropsychological tests that target core and extended social and affective cognitive processes, observer-rated measures of social behavior during the exam, and partner-completed questionnaires about everyday behavior. Eligible participants without contraindications will also undergo MRI to map brain regions associated with test performance and observed behavior. The study will use correlation and imaging analyses to identify relationships between social cognition measures, real-world social behavior, and underlying brain networks.
Who should consider this trial
Good fit: Ideal candidates are French-speaking adults aged 40–85 with a diagnosis of Alzheimer's disease or the semantic or behavioral variant of frontotemporal degeneration who have a study partner, are registered with French social security, and can safely undergo MRI.
Not a fit: People who cannot have an MRI, have dementia from non-neurodegenerative causes, severe cerebrovascular disease, other neurodegenerative or serious neurological disorders, or uncorrected sensory deficits are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could clarify which social and emotional deficits drive difficult behaviors and suggest targets for earlier diagnosis or personalized behavioral and rehabilitative approaches.
How similar studies have performed: Previous work has linked social and affective cognitive deficits to behavioral problems—particularly in frontotemporal dementia—but few studies have directly correlated detailed social cognition testing with examiner-observed behavior and brain imaging across combined Alzheimer's and FTD-related cohorts, so this correlative imaging approach is partially novel.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Lille
- Lille University Hospital — Lille, France (Recruiting)
Study contacts
- Principal investigator: Thibaud LEBOUVIER, MD, PhD — University Hospital, Lille
- Study coordinator: Thibaud LEBOUVIER, MD, PhD
- Email: Thibaud.LEBOUVIER@chu-lille.fr
- Phone: 3.20.44.60.21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.