Frontotemporal Dementia, Behavioral VariantSELFSOCNCT07531732
Links Between Self-awareness and Sociocognitive Processes in Neurodegenerative Diseases
An observational study of Frontotemporal Dementia, Behavioral Variant and Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This monocentric, non-interventional study (SELFSOC) investigates the relationship between self-awareness and social cognition in patients with behavioral variant frontotemporal dementia (bvFTD) and Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Frontotemporal Dementia, Behavioral Variant, Alzheimer Disease
- What is being tested?
- Computer-based facial expression recognition task, Computerized affective task and UCLA Structured Insight Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2026to Dec 2027
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with behavioral variant frontotemporal lobar degeneration (bvFTD) or Alzheimer's disease (AD) at a mild to moderate stage.
Who may be able to join
- Diagnosis of possible or probable behavioral variant frontotemporal dementia according to the Rascovsky 2011 criteria (DLFTvc group) OR
- Diagnosis of Alzheimer's disease according to the Jack 2018 criteria, including biomarkers (MA group)
- Mini-Mental State Examination (MMSE) ≥ 20
- Age: 50-80 years
- Sufficient reading and writing proficiency in French to enable completion of the study procedures, in the investigator's opinion
Who cannot join
- Moderate to severe language disorders: Confrontation naming (DO 40 scale) ≤ 32
- Inability to perform computerized tasks according to the investigator's opinion
- Other neurological disorders (including epilepsy, Lewy body disease, vascular dementia)
- Psychiatric comorbidities (bipolar disorder, schizophrenia, current major depressive episode)
- Uncorrected visual impairment
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
Cognitive Neurology Center, Lariboisière-Fernand Widal Hospital Group, APHP
Paris, 75010
Emmanuel Cognat, MD PhD, +33 (0) 1 40 05 49 54, emmanuel.cognat@aphp.fr
About this study
Official title: Study of the Links Between Self-awareness and Sociocognitive Processes in Neurodegenerative Diseases in People With Frontotemporal Lobar Degeneration, Behavioral Variant and Alzheimer's Disease
This monocentric, non-interventional study (SELFSOC) investigates the relationship between self-awareness and social cognition in patients with behavioral variant frontotemporal dementia (bvFTD) and Alzheimer's disease (AD).
The primary objective is to assess metacognitive efficiency related to social cognitive performance using a computerized facial emotion recognition task combined with confidence judgments. Metacognitive indices (including Mratio) will quantify the correspondence between subjective and objective performance.
Thirty-four participants (17 bvFTD, 17 AD; age 50-80; MMSE ≥20) will complete two study visits involving tasks assessing emotion recognition, theory of mind, and memory.
Read the detailed description
Self-awareness impairments are common in neurodegenerative diseases, yet their relationship with social cognition remains poorly understood. This study aims to characterize metacognitive processes associated with social cognition in bvFTD and AD, and to determine whether these processes differ across diagnostic groups.
The primary objective is to evaluate metacognitive efficiency during a facial emotion recognition task using trial-by-trial retrospective confidence judgments, allowing computation of Mratio. This index reflects the alignment between perceived and actual performance.
Secondary objectives include: (1) assessing additional metacognitive measures (prospective and global judgments), (2) comparing metacognition between bvFTD and AD, (3) examining correlations between metacognitive judgments and social cognitive performance, (4) testing domain specificity by comparing social cognition and memory, (5) evaluating the effect of task complexity, (6) assessing the impact of performance feedback, (7) comparing subjective versus objective metacognitive assessments, (8) investigating the role of anosognosia in AD, and (9) exploring associations with hypnotic suggestibility.
Participants will attend two visits (~2 hours each). The first visit includes eligibility assessment, sociodemographic data collection, and a computerized emotion recognition task with metacognitive judgments. The second visit includes additional computerized tasks assessing theory of mind and memory, and an optional hypnotic suggestibility assessment.
Statistical analyses will include between-group comparisons using non-parametric tests, within-subject analyses, and exploratory correlational and regression analyses.
- Being tested
- Computer-based facial expression recognition task, Computerized affective task, UCLA Structured Insight Interview, Barber's Standardized Suggestibility Scale
- Keywords
- Metacognition, Social cognition, Emotion recognition, Theory of Mind, Neuropsychology, Hypnotic suggestibility
- Medical subject headings
- Pick Disease of the Brain, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based facial expression recognition taskBehavioural
Eighteen facial photographs from the FACES database (Ebner et al., 2010) were selected, each depicting one of six emotions: joy, sadness, disgust, fear, anger, and neutral. For each face, the patient must identify the emotion being expressed by choosing from six verbal labels displayed on the screen.
Computerized affective taskBehavioural
The task consists of 32 silent black-and-white videos featuring two characters interacting in a social situation, adapted from the Pierre and Marie task (Caillaud et al., 2020). Each video lasts between 8 and 9 seconds and shows one of the two characters experiencing a specific emotion. Patients will be asked to infer the emotion felt by that character. The emotions depicted are either positive or negative and vary in complexity: embarrassment, pride, anger, and surprise (8 videos for each emotion). After each video, the name of an emotion will appear on the screen, and patients will be asked to indicate whether the displayed emotion matches the one felt by the protagonist (half of the options will be congruent and the other half incongruent). The measured variable will be the rate of correct responses.
UCLA Structured Insight InterviewBehavioural
The UCLA Structured Insight Interview (Mendez \& Shapira, 2011), translated into French, will be used to quantify anosognosia. This is a structured interview, conducted by the investigator, designed to assess patients' awareness of their symptoms in cases of neurodegenerative disease.
Barber's Standardized Suggestibility ScaleBehavioural
The participant, who must keep their eyes closed throughout the administration of the scale, receives a standardized series of suggestions read aloud by the experimenter in a specific order. These suggestions pertain to motor, sensory, verbal, and mnemonic responses (lowering or raising the arm, clenching the hands, feeling thirsty, speech inhibition, immobility, post-hypnotic response, and amnesia).The scale consists of 8 items and is therefore scored on a scale of 0 to 8 : minimum score 0/8 = no suggestibility; maximum score 8/8 = maximum suggestibility.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Variant Frontotemporal Dementia (bvFTD) | Participants diagnosed with behavioral variant frontotemporal dementia according to established clinical criteria (Rascovsky et al., 2011). Patients are aged 50-80 years with mild to moderate disease severity (MMSE ≥20). Receives: Behavioral: Computer-based facial expression recognition task; Behavioral: Computerized affective task; Behavioral: UCLA Structured Insight Interview; Behavioral: Barber's Standardized Suggestibility Scale | |
| Alzheimer's Disease (AD) | Participants diagnosed with Alzheimer's disease based on biomarker-supported criteria (A+T+; Jack et al., 2018). Patients are aged 50-80 years with mild to moderate disease severity (MMSE ≥20). Receives: Behavioral: Computer-based facial expression recognition task; Behavioral: Computerized affective task; Behavioral: UCLA Structured Insight Interview; Behavioral: Barber's Standardized Suggestibility Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metacognitive efficiency during facial emotion recognition (Mratio)
Metacognitive efficiency (Mratio) derived from a computerized facial emotion recognition task with trial-by-trial retrospective confidence judgments. This measure quantifies the correspondence between subjective confidence and objective performance in social cognition.
Measured: Day 0
Secondary outcomes (9)
Prospective and global metacognitive judgments
Assessment of metacognitive performance using prospective (pre-task) and global (post-task) confidence judgments related to social cognitive tasks.
Measured: Day 0, with the second evaluation taking place between Day 1 and Day 20.
Between-group differences in metacognitive efficiency
Comparison of metacognitive indices (including Mratio) between bvFTD and Alzheimer's disease groups during social cognition tasks.
Measured: Day 0, with the second evaluation taking place between Day 1 and Day 20
Association between metacognition and social cognition performance
Correlation between metacognitive judgments and objective performance on social cognition tasks (emotion recognition and theory of mind).
Measured: Day 0, with the second evaluation taking place between Day 1 and Day 20
Domain specificity of metacognition (social cognition vs memory)
Comparison of metacognitive efficiency indices (Mratio) between social cognition tasks and memory tasks.
Measured: A single evaluation conducted between Day 1 and Day 20
Effect of task complexity on metacognitive performance
Comparison of metacognitive performance across tasks of varying complexity (low-level emotion recognition vs higher-level theory of mind).
Measured: A single evaluation conducted between Day 1 and Day 20
Effect of feedback on metacognitive adjustment
Evaluation of changes in metacognitive judgments following feedback on actual performance.
Measured: Day 0, with the second evaluation taking place between Day 1 and Day 20
Subjective versus objective metacognitive assessment
Comparison between questionnaire-based (subjective) and task-based (objective) metacognitive measures and their relationship with social cognition.
Measured: Day 0, with the second evaluation taking place between Day 1 and Day 20
Impact of anosognosia on social cognition in Alzheimer's disease
Comparison of social cognitive and metacognitive performance between Alzheimer's disease patients with and without anosognosia.
Measured: Day 0, with the second evaluation taking place between Day 1 and Day 20
Association between hypnotic suggestibility and metacognition
Exploration of the relationship between hypnotic suggestibility scores and metacognitive performance in bvFTD and AD patients.
Measured: A single optional evaluation conducted between Day 1 and Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Frontotemporal Dementia, Behavioral VariantStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de psychologie, Université Paris Cité, Laboratoire Mémoire, Cerveau, Cognition
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531732
- Sponsor's protocol ID
- APHP251424
- Other IDs
- 2025-A02199-40
- Acronym
- SELFSOC
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mendez MF, Shapira JS. Loss of emotional insight in behavioral variant frontotemporal dementia or "frontal anosodiaphoria". Conscious Cogn. 2011 Dec;20(4):1690-6. doi: 10.1016/j.concog.2011.09.005. Epub 2011 Sep 29.
PubMed 21959203Caillaud M, Bejanin A, Laisney M, Gagnepain P, Gaubert M, Viard A, Clochon P, de La Sayette V, Allain P, Eustache F, Desgranges B. Influence of emotional complexity on the neural substrates of affective theory of mind. Hum Brain Mapp. 2020 Jan;41(1):139-149. doi: 10.1002/hbm.24794. Epub 2019 Sep 30.
PubMed 31566290Ebner NC, Riediger M, Lindenberger U. FACES--a database of facial expressions in young, middle-aged, and older women and men: development and validation. Behav Res Methods. 2010 Feb;42(1):351-62. doi: 10.3758/BRM.42.1.351.
PubMed 20160315Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
PubMed 29653606Rascovsky K, Hodges JR, Knopman D, Mendez MF, Kramer JH, Neuhaus J, van Swieten JC, Seelaar H, Dopper EG, Onyike CU, Hillis AE, Josephs KA, Boeve BF, Kertesz A, Seeley WW, Rankin KP, Johnson JK, Gorno-Tempini ML, Rosen H, Prioleau-Latham CE, Lee A, Kipps CM, Lillo P, Piguet O, Rohrer JD, Rossor MN, Warren JD, Fox NC, Galasko D, Salmon DP, Black SE, Mesulam M, Weintraub S, Dickerson BC, Diehl-Schmid J, Pasquier F, Deramecourt V, Lebert F, Pijnenburg Y, Chow TW, Manes F, Grafman J, Cappa SF, Freedman M, Grossman M, Miller BL. Sensitivity of revised diagnostic criteria for the behavioural variant of frontotemporal dementia. Brain. 2011 Sep;134(Pt 9):2456-77. doi: 10.1093/brain/awr179. Epub 2011 Aug 2.
PubMed 21810890
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Links Between Self-awareness and Sociocognitive Processes in Neurodegenerative Diseases in People With Frontotemporal Lobar Degeneration, Behavioral Variant and Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07531732
- Acronym / sponsor ID
- SELFSOC / APHP251424
- Keywords
- Metacognition, Social cognition, Emotion recognition, Theory of Mind, Neuropsychology, Hypnotic suggestibility
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut de psychologie, Université Paris Cité, Laboratoire Mémoire, Cerveau, Cognition
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Apr 2026 (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.
This monocentric, non-interventional study (SELFSOC) investigates the relationship between self-awareness and social cognition in patients with behavioral variant frontotemporal dementia (bvFTD) and Alzheimer's disease (AD).
The primary objective is to assess metacognitive efficiency related to social cognitive performance using a computerized facial emotion recognition task combined with confidence judgments. Metacognitive indices (including Mratio) will quantify the correspondence between subjective and objective performance.
Thirty-four participants (17 bvFTD, 17 AD; age 50-80; MMSE ≥20) will complete two study visits involving tasks assessing emotion recognition, theory of mind, and memory.
Detailed description
Self-awareness impairments are common in neurodegenerative diseases, yet their relationship with social cognition remains poorly understood. This study aims to characterize metacognitive processes associated with social cognition in bvFTD and AD, and to determine whether these processes differ across diagnostic groups.
The primary objective is to evaluate metacognitive efficiency during a facial emotion recognition task using trial-by-trial retrospective confidence judgments, allowing computation of Mratio. This index reflects the alignment between perceived and actual performance.
Secondary objectives include: (1) assessing additional metacognitive measures (prospective and global judgments), (2) comparing metacognition between bvFTD and AD, (3) examining correlations between metacognitive judgments and social cognitive performance, (4) testing domain specificity by comparing social cognition and memory, (5) evaluating the effect of task complexity, (6) assessing the impact of performance feedback, (7) comparing subjective versus objective metacognitive assessments, (8) investigating the role of anosognosia in AD, and (9) exploring associations with hypnotic suggestibility.
Participants will attend two visits (~2 hours each). The first visit includes eligibility assessment, sociodemographic data collection, and a computerized emotion recognition task with metacognitive judgments. The second visit includes additional computerized tasks assessing theory of mind and memory, and an optional hypnotic suggestibility assessment.
Statistical analyses will include between-group comparisons using non-parametric tests, within-subject analyses, and exploratory correlational and regression analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Variant Frontotemporal Dementia (bvFTD) | – | Behavioral: Computer-based facial expression recognition task, Behavioral: Computerized affective task, Behavioral: UCLA Structured Insight Interview, Behavioral: Barber's Standardized Suggestibility ScaleParticipants diagnosed with behavioral variant frontotemporal dementia according to established clinical criteria (Rascovsky et al., 2011). Patients are aged 50-80 years with mild to moderate disease severity (MMSE ≥20). |
| Alzheimer's Disease (AD) | – | Behavioral: Computer-based facial expression recognition task, Behavioral: Computerized affective task, Behavioral: UCLA Structured Insight Interview, Behavioral: Barber's Standardized Suggestibility ScaleParticipants diagnosed with Alzheimer's disease based on biomarker-supported criteria (A+T+; Jack et al., 2018). Patients are aged 50-80 years with mild to moderate disease severity (MMSE ≥20). |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with behavioral variant frontotemporal lobar degeneration (bvFTD) or Alzheimer's disease (AD) at a mild to moderate stage.
Key inclusion criteria (5 listed)
- Diagnosis of possible or probable behavioral variant frontotemporal dementia according to the Rascovsky 2011 criteria (DLFTvc group) OR
- Diagnosis of Alzheimer's disease according to the Jack 2018 criteria, including biomarkers (MA group)
- Mini-Mental State Examination (MMSE) ≥ 20
- Age: 50-80 years
- Sufficient reading and writing proficiency in French to enable completion of the study procedures, in the investigator's opinion
Key exclusion criteria (5 listed)
- Moderate to severe language disorders: Confrontation naming (DO 40 scale) ≤ 32
- Inability to perform computerized tasks according to the investigator's opinion
- Other neurological disorders (including epilepsy, Lewy body disease, vascular dementia)
- Psychiatric comorbidities (bipolar disorder, schizophrenia, current major depressive episode)
- Uncorrected visual impairment
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 |
|---|---|---|
| Computer-based facial expression recognition taskEighteen facial photographs from the FACES database (Ebner et al., 2010) were selected, each depicting one of six emotions: joy, sadness, disgust, fear, anger, and neutral. For each face, the patient must identify the emotion being expressed by choosing from six verbal labels displayed on the screen. | Behavioural | Alzheimer's Disease (AD), Behavioral Variant Frontotemporal Dementia (bvFTD) |
| Computerized affective taskThe task consists of 32 silent black-and-white videos featuring two characters interacting in a social situation, adapted from the Pierre and Marie task (Caillaud et al., 2020). Each video lasts between 8 and 9 seconds and shows one of the two characters experiencing a specific emotion. Patients will be asked to infer the emotion felt by that character. The emotions depicted are either positive or negative and vary in complexity: embarrassment, pride, anger, and surprise (8 videos for each emotion). After each video, the name of an emotion will appear on the screen, and patients will be asked to indicate whether the displayed emotion matches the one felt by the protagonist (half of the options will be congruent and the other half incongruent). The measured variable will be the rate of correct responses. | Behavioural | Alzheimer's Disease (AD), Behavioral Variant Frontotemporal Dementia (bvFTD) |
| UCLA Structured Insight InterviewThe UCLA Structured Insight Interview (Mendez \& Shapira, 2011), translated into French, will be used to quantify anosognosia. This is a structured interview, conducted by the investigator, designed to assess patients' awareness of their symptoms in cases of neurodegenerative disease. | Behavioural | Alzheimer's Disease (AD), Behavioral Variant Frontotemporal Dementia (bvFTD) |
| Barber's Standardized Suggestibility ScaleThe participant, who must keep their eyes closed throughout the administration of the scale, receives a standardized series of suggestions read aloud by the experimenter in a specific order. These suggestions pertain to motor, sensory, verbal, and mnemonic responses (lowering or raising the arm, clenching the hands, feeling thirsty, speech inhibition, immobility, post-hypnotic response, and amnesia).The scale consists of 8 items and is therefore scored on a scale of 0 to 8 : minimum score 0/8 = no suggestibility; maximum score 8/8 = maximum suggestibility. | Behavioural | Alzheimer's Disease (AD), Behavioral Variant Frontotemporal Dementia (bvFTD) |
Primary outcome
Metacognitive efficiency during facial emotion recognition (Mratio)
Time frame: Day 0
Metacognitive efficiency (Mratio) derived from a computerized facial emotion recognition task with trial-by-trial retrospective confidence judgments. This measure quantifies the correspondence between subjective confidence and objective performance in social cognition.
9 secondary outcomes
Prospective and global metacognitive judgments
Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20.
Between-group differences in metacognitive efficiency
Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20
Association between metacognition and social cognition performance
Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20
Domain specificity of metacognition (social cognition vs memory)
Time frame: A single evaluation conducted between Day 1 and Day 20
Effect of task complexity on metacognitive performance
Time frame: A single evaluation conducted between Day 1 and Day 20
Effect of feedback on metacognitive adjustment
Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20
Subjective versus objective metacognitive assessment
Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20
Impact of anosognosia on social cognition in Alzheimer's disease
Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20
Association between hypnotic suggestibility and metacognition
Time frame: A single optional evaluation conducted between Day 1 and Day 20
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 15 Apr 2026.
- Background: PubMed 21959203Mendez MF, Shapira JS. Loss of emotional insight in behavioral variant frontotemporal dementia or "frontal anosodiaphoria". Conscious Cogn. 2011 Dec;20(4):1690-6. doi: 10.1016/j.concog.2011.09.005. Epub 2011 Sep 29.
- Background: PubMed 31566290Caillaud M, Bejanin A, Laisney M, Gagnepain P, Gaubert M, Viard A, Clochon P, de La Sayette V, Allain P, Eustache F, Desgranges B. Influence of emotional complexity on the neural substrates of affective theory of mind. Hum Brain Mapp. 2020 Jan;41(1):139-149. doi: 10.1002/hbm.24794. Epub 2019 Sep 30.
- Background: PubMed 20160315Ebner NC, Riediger M, Lindenberger U. FACES--a database of facial expressions in young, middle-aged, and older women and men: development and validation. Behav Res Methods. 2010 Feb;42(1):351-62. doi: 10.3758/BRM.42.1.351.
- Background: PubMed 29653606Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
- Background: PubMed 21810890Rascovsky K, Hodges JR, Knopman D, Mendez MF, Kramer JH, Neuhaus J, van Swieten JC, Seelaar H, Dopper EG, Onyike CU, Hillis AE, Josephs KA, Boeve BF, Kertesz A, Seeley WW, Rankin KP, Johnson JK, Gorno-Tempini ML, Rosen H, Prioleau-Latham CE, Lee A, Kipps CM, Lillo P, Piguet O, Rohrer JD, Rossor MN, Warren JD, Fox NC, Galasko D, Salmon DP, Black SE, Mesulam M, Weintraub S, Dickerson BC, Diehl-Schmid J, Pasquier F, Deramecourt V, Lebert F, Pijnenburg Y, Chow TW, Manes F, Grafman J, Cappa SF, Freedman M, Grossman M, Miller BL. Sensitivity of revised diagnostic criteria for the behavioural variant of frontotemporal dementia. Brain. 2011 Sep;134(Pt 9):2456-77. doi: 10.1093/brain/awr179. Epub 2011 Aug 2.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frontotemporal Dementia, Behavioral Variant and Alzheimer Disease, 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 5 inclusion and 5 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 15 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 Emmanuel Cognat, MD PhD (+33 (0) 1 40 05 49 54, emmanuel.cognat@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metacognitive efficiency during facial emotion recognition (Mratio) (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07531732, which also lists 5 linked publications.
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 15 Apr 2026.