Alzheimer's DiseaseSOCIALIZENCT06338397
Social & Affective Cognition in Alzheimer's Disease & Associated Disorders
A study testing SCANN in people with Alzheimer's Disease and Frontotemporal Degeneration (Semantic & Behavioral Variants), run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Frontotemporal Degeneration (Semantic & Behavioral Variants)
- What is being tested?
- SCANN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2025to 2 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Lille University Hospital
Lille, 59000
DRI, 3.20.44.41.45 ext. +33, drs.promotion@chu-lille.fr
About this study
Official title: 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.
- Being tested
- SCANN
- Keywords
- Emotions, social cognition, social semantics, neuropsychology, frontotemporal dementia
- Medical subject headings
- Alzheimer Disease, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCANNOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Social & affective cognition assessment | Experimental | Not described Receives: Other: SCANN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between the mini Social cognition & Emotional Assessment - mini-SEA - total score and the Social Behavior Observer Checklist - SBOC - score in all participants.
Measured: 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.
Measured: 1 day
Correlation coefficient between the SBOC score with MRI markers in all participants
Measured: 1 day
Correlation coefficient between mini-SEA sub scores & MRI markers in all participants.
Measured: 1 day
Correlation coefficients between mini-SEA sub scores with the SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups.
Measured: 1 day
Correlation coefficients between SCANN sub-scores and the SBOC, SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start28 Jan 2025
- Primary completion28 Jan 2028 (estimated)
- Study completion2 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- France Alzheimer
- Responsible party
- Sponsor
- Investigators
- Thibaud LEBOUVIER, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338397
- Sponsor's protocol ID
- 2023_0455
- Acronym
- SOCIALIZE
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social & Affective Cognition as Determinant of Social Behavior in Alzheimer's Disease & Associated Disorders
- ClinicalTrials.gov ID
- NCT06338397
- Acronym / sponsor ID
- SOCIALIZE / 2023_0455
- Keywords
- Emotions, social cognition, social semantics, neuropsychology, frontotemporal dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- France Alzheimer
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 28 Jan 2028 (estimated)
- Study completion
- 2 May 2028 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social & affective cognition assessment | Experimental | Other: SCANN |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCANNAdministering 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. | Other | Social & affective cognition assessment |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thibaud LEBOUVIER, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCANN in people with Alzheimer's Disease and Frontotemporal Degeneration (Semantic & Behavioral Variants), run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thibaud LEBOUVIER, MD, PhD (3.20.44.60.21 ext. +33, Thibaud.LEBOUVIER@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.