Alzheimer's Disease (AD)REALSOCOGNCT05558709
Social-cognitive Functioning: Validation of a New Neuropsychological Test
A study testing REALSOCOG, BCS and Hetero-questionnaires in people with Alzheimer's Disease (AD) and Lewy Body Dementia (LBD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
It is now established that disturbances in social cognition are frequent in neurology and that they contribute to the development of social conduct disorders. Their assessment is therefore essential, particularly in order to propose early and adapted care. However, this assessment remains limited today. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease (AD), Lewy Body Dementia (LBD), Frontotemporal Degeneration (FTD)
- What is being tested?
- REALSOCOG, BCS and Hetero-questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2026to 4 Feb 2030
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For patients:
- Patient aged between 18 and 90 years
- Mini Mental State Examination (MMSE) score greater than or equal to 20
- Patient able to express his or her non-opposition to participate in the study in an informed and autonomous manner
- Patient with a neurodegenerative pathology: FTD, AD or LBD.
- For caregivers:
- Over 18 years of age
- Regular contact with the patient (≥ 2 times per month)
Who cannot join
- For patients:
- Neurological or psychiatric comorbidity
- Notable sensory disorders (e.g., profound or total deafness, age-related macular degeneration, blindness, etc.) that may interfere with experimental completion.
- Opposition to participation in the study
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
Hôpital de la Pitié-Salpêtrière
Paris, 75013
Marc VERNY, Pr, 01 42 16 03 12 ext. +33, marc.verny@aphp.fr
About this study
Official title: Social-cognitive Functioning: Validation of a New Neuropsychological Test and Prediction of Social Behavioural Disorders in Daily Life
It is now established that disturbances in social cognition are frequent in neurology and that they contribute to the development of social conduct disorders. Their assessment is therefore essential, particularly in order to propose early and adapted care. However, this assessment remains limited today. A new serious game-type test, REALSoCog, has been developed to address the shortcomings of current tools and to highlight disturbances in social behaviors. The latter are not always observed in consultation although they are often reported by caregivers. The objective of this research is therefore to validate the REALSoCog task in a pathological population (currently being standardized in the general population: CER-U, IRB N°: 00012020-115). The clinical interest of this task will be tested with a group of patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL), fronto-temporal lobar degeneration (FTD)) in order to assess its sensitivity and specificity in the detection of social-cognitive disturbances, and in particular in terms of social behaviors (detection of social behavioral disorders reported in daily life). The objective is also to document the socio-cognitive profiles in the mentioned diseases thanks to a more ecological test, and to better understand the links between socio-cognitive processes on the one hand, and individual characteristics on the other hand (e.g. mood and social participation).
Read the detailed description
It is now established that disturbances in social cognition are frequent in neurology and that they contribute to the development of social conduct disorders. Their assessment is therefore essential, particularly in order to propose early and adapted care. However, this assessment remains limited today. A new serious game-type test, REALSoCog, has been developed to address the shortcomings of current tools and to highlight disturbances in social behaviors. The latter are not always observed in consultation although they are often reported by caregivers. The objective of this research is therefore to validate the REALSoCog task in a pathological population (currently being standardized in the general population: CER-U, IRB N°: 00012020-115). The clinical interest of this task will be tested with a group of patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL), fronto-temporal lobar degeneration (FTD)) in order to assess its sensitivity and specificity in the detection of social-cognitive disturbances, and in particular in terms of social behaviors (detection of social behavioral disorders reported in daily life). The objective is also to document the socio-cognitive profiles in the mentioned diseases thanks to a more ecological test, and to better understand the links between socio-cognitive processes on the one hand, and individual characteristics on the other hand (e.g. mood and social participation).
- Being tested
- REALSOCOG, BCS, Hetero-questionnaires
- Keywords
- Neurodegenerative diseases, Social behavior, Social cognition, Neuropsychological assessment
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease, Neurodegenerative Diseases, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REALSOCOGOther
Also called neuropsychological test
Patients will be asked to perform the REALSoCog serious game-type social cognition assessment task developed by the LMC2 laboratory (UR 7536). Their performance will be compared to those of control individuals recruited in parallel (independant clinical study: CER-U, IRB N°: 00012020-115). Participants will be asked to think about 16 social situations (6 control situations and 10 experimental situations) encountered in a virtual environment representing a city. REALSoCog can be used on a laptop computer, without any additional technical device.
BCSOther
Also called Social-Cognition Battery
Social-cognitive tasks from the BCS (Ehrlé et al., 2011) will also be offered to patients to test the concurrent validity of REALSoCog. This battery assesses social cognition. It includes paper-and-pencil tasks.
Hetero-questionnairesOther
Hetero-questionnaires assessing patients' social behavior will be transmitted to their relative or primary caregiver (Godefroy \& le GREFEX, 2008; Gury and Ehrlé, in progress of validation) in order to verify the concurrent validity of REALSoCog. These hetero-questionnaires aim to identify and quantify the presence of social skills and behaviour disorders.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL) or fronto-temporal lobar degeneration (FTD)) Receives: Other: REALSOCOG; Other: BCS |
| Relatives | Other | Caregivers or relatives of included patients, having regular contact with the patient (≥ 2 times per month). Receives: Other: Hetero-questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of inappropriate behavioural intentions
It is measured by the REALSoCog task through a question asking the participant to specify his behavioral intention in the case where he would have declared his intention to act in front of the social situation presented. These questions are asked for each social situation presented, i.e. for a total of 16 situations
Measured: 1 hour and a half
Secondary outcomes (3)
Assessment of Moral cognition
The ability to detect moral transgressions, the ability to detect conventional transgressions, and the ability to detect control situations (non-transgressive situations) are measured by the question "Does this situation seem appropriate or inappropriate to you?" asked after each REALSoCog situation. The severity judgment of moral transgressions and the severity judgment of conventional transgressions are measured by the question "How inappropriate does it [the situation] seem to you?" asked after each response characterizing the situation presented as inappropriate in REALSoCog.
Measured: 1 hour and a half
Evaluation of Empathy and emotional reactivity
The intensity of emotional empathy and the intensity of emotional reactivity are measured by the question "How much are you affected by the situation? This question is asked after each experimental situation of REALSoCog (i.e. situations involving a transgression and situations constructed to elicit empathy), i.e. for 10 situations.
The valence and congruence of the emotions felt are measured by the question "The emotion you feel at the sight of this situation is: 1 (very negative) to 5 (very positive)". This question is asked after each experimental situation of REALSoCog (i.e. situations involving a transgression and situations constructed to elicit empathy), i.e. for 10 situations.
Measured: 1 hour and a half
Assessment of theory of mind
The ability to detect the intentionality of an action is measured by the question "Is the behavior of the [main protagonist in the situation] intentional? Yes / No". This question is asked for 5 REALSoCog situations.
The ability to characterize the valence of this intention and the average valence of the attributed intentions is measured by the question "In your opinion the intention is: 1 (very malicious) to 5 (very benevolent)". This question is asked for 5 REALSoCog situations.
The ability to infer an affect to others is measured by the question "How does [main protagonist of the situation] feel?". This question is asked for 8 REALSoCog situations.
The intensity of the affect attributed to others is measured by the question "How does [main protagonist of the situation] feel about [subject's response to the previous question]?" This question is asked for 8 REALSoCog situations.
Measured: 1 hour and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start4 Feb 2026
- Primary completion4 Feb 2029 (estimated)
- Study completion4 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc VERNY, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558709
- Sponsor's protocol ID
- APHP220748
- Acronym
- REALSOCOG
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2022
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social-cognitive Functioning: Validation of a New Neuropsychological Test and Prediction of Social Behavioural Disorders in Daily Life
- ClinicalTrials.gov ID
- NCT05558709
- Acronym / sponsor ID
- REALSOCOG / APHP220748
- Keywords
- Neurodegenerative diseases, Social behavior, Social cognition, Neuropsychological assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 4 Feb 2029 (estimated)
- Study completion
- 4 Feb 2030 (estimated)
- First posted
- 28 Sep 2022 (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.
It is now established that disturbances in social cognition are frequent in neurology and that they contribute to the development of social conduct disorders. Their assessment is therefore essential, particularly in order to propose early and adapted care. However, this assessment remains limited today. A new serious game-type test, REALSoCog, has been developed to address the shortcomings of current tools and to highlight disturbances in social behaviors. The latter are not always observed in consultation although they are often reported by caregivers. The objective of this research is therefore to validate the REALSoCog task in a pathological population (currently being standardized in the general population: CER-U, IRB N°: 00012020-115). The clinical interest of this task will be tested with a group of patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL), fronto-temporal lobar degeneration (FTD)) in order to assess its sensitivity and specificity in the detection of social-cognitive disturbances, and in particular in terms of social behaviors (detection of social behavioral disorders reported in daily life). The objective is also to document the socio-cognitive profiles in the mentioned diseases thanks to a more ecological test, and to better understand the links between socio-cognitive processes on the one hand, and individual characteristics on the other hand (e.g. mood and social participation).
Detailed description
It is now established that disturbances in social cognition are frequent in neurology and that they contribute to the development of social conduct disorders. Their assessment is therefore essential, particularly in order to propose early and adapted care. However, this assessment remains limited today. A new serious game-type test, REALSoCog, has been developed to address the shortcomings of current tools and to highlight disturbances in social behaviors. The latter are not always observed in consultation although they are often reported by caregivers. The objective of this research is therefore to validate the REALSoCog task in a pathological population (currently being standardized in the general population: CER-U, IRB N°: 00012020-115). The clinical interest of this task will be tested with a group of patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL), fronto-temporal lobar degeneration (FTD)) in order to assess its sensitivity and specificity in the detection of social-cognitive disturbances, and in particular in terms of social behaviors (detection of social behavioral disorders reported in daily life). The objective is also to document the socio-cognitive profiles in the mentioned diseases thanks to a more ecological test, and to better understand the links between socio-cognitive processes on the one hand, and individual characteristics on the other hand (e.g. mood and social participation).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: REALSOCOG, Other: BCSPatients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL) or fronto-temporal lobar degeneration (FTD)) |
| Relatives | Other | Other: Hetero-questionnairesCaregivers or relatives of included patients, having regular contact with the patient (≥ 2 times per month). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient aged between 18 and 90 years
- Mini Mental State Examination (MMSE) score greater than or equal to 20
- Patient able to express his or her non-opposition to participate in the study in an informed and autonomous manner
- Patient with a neurodegenerative pathology: FTD, AD or LBD.
- Over 18 years of age
Key exclusion criteria (4 listed)
- Neurological or psychiatric comorbidity
- Notable sensory disorders (e.g., profound or total deafness, age-related macular degeneration, blindness, etc.) that may interfere with experimental completion.
- Opposition to participation in 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 |
|---|---|---|
| REALSOCOGAlso: neuropsychological testPatients will be asked to perform the REALSoCog serious game-type social cognition assessment task developed by the LMC2 laboratory (UR 7536). Their performance will be compared to those of control individuals recruited in parallel (independant clinical study: CER-U, IRB N°: 00012020-115). Participants will be asked to think about 16 social situations (6 control situations and 10 experimental situations) encountered in a virtual environment representing a city. REALSoCog can be used on a laptop computer, without any additional technical device. | Other | Patients |
| BCSAlso: Social-Cognition BatterySocial-cognitive tasks from the BCS (Ehrlé et al., 2011) will also be offered to patients to test the concurrent validity of REALSoCog. This battery assesses social cognition. It includes paper-and-pencil tasks. | Other | Patients |
| Hetero-questionnairesHetero-questionnaires assessing patients' social behavior will be transmitted to their relative or primary caregiver (Godefroy \& le GREFEX, 2008; Gury and Ehrlé, in progress of validation) in order to verify the concurrent validity of REALSoCog. These hetero-questionnaires aim to identify and quantify the presence of social skills and behaviour disorders. | Other | Relatives |
Primary outcome
rate of inappropriate behavioural intentions
Time frame: 1 hour and a half
It is measured by the REALSoCog task through a question asking the participant to specify his behavioral intention in the case where he would have declared his intention to act in front of the social situation presented. These questions are asked for each social situation presented, i.e. for a total of 16 situations
3 secondary outcomes
Assessment of Moral cognition
Time frame: 1 hour and a half
Evaluation of Empathy and emotional reactivity
Time frame: 1 hour and a half
Assessment of theory of mind
Time frame: 1 hour and a half
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 13 Mar 2026.
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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.
Marc VERNY, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REALSOCOG, BCS and Hetero-questionnaires in people with Alzheimer's Disease (AD) and Lewy Body Dementia (LBD), run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 4 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 13 Mar 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 Marc VERNY, Pr (01 42 16 03 12 ext. +33, marc.verny@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of inappropriate behavioural intentions (time frame: 1 hour and a half). 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 13 Mar 2026.