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Clinical Trials in France / NCT07573046
Starting soon Observational

Validation Study of the ExéSem Battery Designed to Differentiate the Contribution of Executive Functions in Semantic Disorders

NCT07573046 · tracked via the Priya Life Science France tracker
Sponsor
Hospices Civils de Lyon
Phase
Observational
Started
2026-09-09
Last updated
2026-05-07

Condition(s) studied

Alzheimer's DiseaseVascular Neurocognitive DisorderProgressive Primary Aphasia Semantic VariantPeople Without Neurocognitive Disorder

Investigational drug(s) / intervention(s)

ExéSem cognitive battery

ExéSem cognitive battery: The ExéSem battery is a neuropsychological assessment tool designed to evaluate semantic processing and the contribution of executive control in patients with or without neurocognitive disorders. It consists of three tasks: (1) a dual task combining semantic judgment and semantic matching using identical items, (2) a word-to-picture matching task, and (3) a rapid naming task. Each task is structured to manipulate the level of executive demand required to access semantic representations. This variation allows the identification of whether semantic difficulties remain stable or worsen under increased executive load, thereby distinguishing primary semantic deficits from executive-related semantic impairments. The battery is administered by a trained professional using standardized instructions and requires approximately 30 minutes to complete. It is used for diagnostic and research purposes only and does not involve any therapeutic intervention.

Study summary

This protocol describes a study aimed at evaluating the psychometric properties of the ExéSem battery, developed to differentiate semantic deficits from executive semantic impairments in patients with post-lesional or neurodegenerative anomia. Currently available tools do not allow a straightforward distinction between these deficits, limiting diagnostic accuracy and clinical management. The ExéSem battery was developed through a collaboration between Hospices Civils de Lyon, the University of Mons, and Laval University to address this gap.

The battery includes three main tasks: (1) a dual task combining semantic judgment and semantic matching using identical items, (2) a word-picture matching task, and (3) a rapid naming task. Each task is designed to manipulate the level of executive control required to access semantic representations. This allows the identification of whether performance declines under increased executive demand, thereby distinguishing executive-related semantic impairments.

Eligibility

Sex
ALL
Min age
50 Years
Max age
90 Years
Healthy volunteers
Accepted
Inclusion Criteria: * \- Participants without cognitive impairment * Participant aged 50 to 90 years (inclusive); * Participant whose native language is French * Participant affiliated with or entitled to a social security scheme; * Participants who have been informed and have not objected. * Participants with cognitive impairment * Participant aged 50 to 90 years (inclusive); * Participant whose native language is French * Participant receiving memory care with a diagnosis of Alzheimer's disease, at the stage of minor or major neurocognitive impairment, according to the 2011 NIA-AA criteria (McKahn et al., 2011), or with a diagnosis of vascular neurocognitive impairment according to the VasCog-2-WSO diagnostic criteria (Sachdev et al., 2025), or with a diagnosis of primary progressive aphasia with semantic variant (Gorno-Tempini et al., 2011). * Mini-Mental State Examination (MMSE) score ≥ 20/30, within the 6 months preceding enrollment; * Participants affiliated with or entitled to a social security scheme; * Participants who have been informed and have not objected. Exclusion Criteria: * \- For all participants: * Severe, progressive, or unstable medical conditions that may interfere with assessment variables (epilepsy, acute psychiatric or psychotic disorders, visual hallucinations, acute infection); * Substance use that may affect cognitive performance; * Deafness or blindness that may compromise the participant's assessment or participation in tasks and scales; * Participants under guardianship, curatorship, or legal protection; * Pregnant, postpartum, or breastfeeding women. * Specifically for participants without cognitive impairment: * Participants previously diagnosed with cognitive impairment. * Specifically for participants with cognitive impairment: * Severe behavioral and psychological symptoms that prevent task completion, as determined by the investigator.

Primary outcome measure(s)

  • Score obtained on the ExéSem battery — At enrollment
    The primary outcome is the total score on the ExéSem battery (max=172), assessing semantic and executive-semantic processing. The battery includes semantic judgment (30 items), semantic matching (20 items), word-image matching (72 items), and rapid naming (50 items). Tasks vary in executive demand to determine whether performance declines under increased cognitive load, distinguishing primary semantic deficits from executive-related impairments.

Trial sites (1)

FacilityCityRegionStatus
Hopital des CHARPENNES ( Hospices Civils de Lyon) Lyon France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07573046 on ClinicalTrials.gov ↗ ← All trials in France