Not Yet RecruitingNot Applicable

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

France140 participantsStarted 2026-09-09

Plain-language 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.

Who can participate

Age range

50 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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; * Par…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Score obtained on the ExéSem battery

Timeframe: At enrollment

Trial details

NCT IDNCT07573046

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-08-31

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