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

Обзор

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.

Подробное описание

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.

The primary objective is to assess the sensitivity of the ExéSem battery by comparing performances between participants with neurocognitive disorders (mild or major) and cognitively healthy controls. Secondary objectives include evaluating specificity, concurrent validity through comparison with established neuropsychological tests (BECLA, Trail Making Test, Stroop), and the influence of demographic variables (age, sex, education level).

This is a prospective, experimental, comparative, single-center study, classified as a non-interventional study involving human participants (RIPH3). Two populations will be included: cognitively healthy individuals and patients diagnosed with Alzheimer's disease, vascular neurocognitive disorder, or semantic variant primary progressive aphasia. Participants will be aged 50 to 90 years, native French speakers, affiliated with a social security system, and informed with non-opposition collected.

The primary endpoint is the total score on the ExéSem battery (maximum score: 172). Secondary endpoints include sub-scores for each task (semantic judgment and matching, word-picture matching, rapid naming), as well as performance on reference tests to assess convergent validity. The effects of age, sex, and education level, as well as task completion times, will also be analyzed.

A single study visit is planned. After receiving information and a reflection period, participants will complete demographic questionnaires and undergo cognitive assessments, including screening tests (MoCA, DTLA for controls), reference tests (Trail Making Test, Stroop, BECLA), and the ExéSem battery. The total duration of testing is approximately 80 minutes, including 30 minutes for ExéSem.

Risks are minimal and mainly related to cognitive fatigue. Participants with abnormal screening results will be referred for further clinical evaluation outside the study. This research aims to improve diagnostic accuracy in semantic disorders and to better guide cognitive rehabilitation strategies.

* Alzheimer's disease * Vascular neurocognitive disorder * Progressive Primary Aphasia semantic variant * People without neurocognitive disorder

Вмешательства

• Диагностический тест 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 var

Первичные конечные точки

• Score obtained on the ExéSem battery [Срок оценки: At enrollment]

Критерии участия

Критерии включения

• \- 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.

Критерии исключения

• \- 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Hopital des CHARPENNES ( Hospices Civils de Lyon) — Lyon

Идентификаторы

NCT: NCT07573046 · 69HCL25_1144 · 2025-A02845-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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