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

NCT07573046 | Not Yet Recruiting

• 2 other identifiers: 69HCL25_11442025-A02845-44
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease; Vascular Neurocognitive Disorder; Progressive Primary Aphasia Semantic Variant; People Without Neurocognitive Disorder

Keywords

Anomia; Semantic disorders; Executive control; Neurocognitive disorders

Outcome Measures

Primary Outcomes (1)

• Score obtained on the ExéSem battery

  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

Study Arms (2)

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.

Diagnostic Test: ExéSem cognitive battery

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;

Diagnostic Test: ExéSem cognitive battery

Interventions

ExéSem cognitive battery DIAGNOSTIC_TEST

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 without cognitive impairment

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital des CHARPENNES ( Hospices Civils de Lyon)

Lyon, 69100, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Anomia; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Mental Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): September 9, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): September 9, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)