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

4. maj 2026 opdateret af: Hospices Civils de Lyon

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Anslået)

140

Kontakter og lokationer

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Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population includes two groups aged 50 to 90 years: cognitively healthy participants and patients with mild to moderate neurocognitive disorders (MMSE ≥20/30), including Alzheimer's disease, vascular neurocognitive disorder, or semantic variant primary progressive aphasia.

Healthy participants are recruited on a voluntary basis through flyers displayed in the Charpennes Hospital and distributed by speech therapy and neuropsychology students. Interested individuals contact the Clinical Research Center (CRC), where they receive initial information during a phone call and are provided with the study information sheet before scheduling an inclusion visit.

Patients with neurocognitive disorders are recruited during routine clinical care (consultation or day hospital assessment).

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Participants without cognitive impairment

Participanst with a MoCA score greater than or equal to 26/30 and a score greater than the alert threshold based on age and education level on the DTLA scale.

Participants who have never received a diagnosis of cognitive impairment.
Diagnostisk test: 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.
Participants with Cognitive Impairment
Participants receiving memory clinic care with a diagnosis of Alzheimer's disease, at the stage of minor or major neurocognitive impairment, according to the 2011 NIA-AA criteria, or with a diagnosis of vascular neurocognitive impairment according to the VasCog-2-WSO diagnostic criteria , or with a diagnosis of primary progressive aphasia with semantic variant. Participants with a Mini-Mental State Examination (MMSE) score ≥ 20/30, within the 6 months preceding enrollment;
Diagnostisk test: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Score obtained on the ExéSem battery
Tidsramme: 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.
At enrollment

Samarbejdspartnere og efterforskere

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Sponsor

Hospices Civils de Lyon

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

9. september 2026

Primær færdiggørelse (Anslået)

31. august 2029

Studieafslutning (Anslået)

9. september 2029

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 69HCL25_1144
  • 2025-A02845-44 (Anden identifikator: ID-RCB)

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