Neuropsychological Evaluation in Intellectual Disability (ENDI)

NCT07047963 | Not Yet Recruiting

• 1 other identifier: 2024- A01565- 42
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the acceptability ofpatients with trisomy 21 (T21) to perform the full battery of ENDI neurospychological tests and each of the subsets. In this study, three types of population will be recruted : normotypic volunteers, patients with Intellectual Disability and patients T21carriers. This study is separated into 2 phases :

• A the preliminary phase : this phase will be used to evaluate subtest design, ergonomics and understanding of instructions, and to identify any malfunctions. The observations gathered will enable the principal investigator to refine the digital design of the battery in collaboration with the publishing company. In this phase, normotypical volunteers and patients with intellectual disabilities will be recruted to perform ENDI test battery.
• A main phase : this phase will enable to answer to the main objective. in this phase, patients with Trisomy 21 aged between 25 and 65 will be recruted to perform ENDI test battery.

Conditions

Down Syndrome (Trisomy 21); Neuropsychology; Cognitive Aging; Alzheimer Disease; Alzheimer Disease, Early Onset

Keywords

Down Syndrome (Trisomy 21); ENDI; Trisomy 21; neuropsychology; ENDI tests battery

Outcome Measures

Primary Outcomes (4)

• Acceptability of individual subtests and the complete test battery

  Acceptability will be estimated by The average completion time for the complete ENDI battery

  Through the study (completion of the full test battery), an average of 45 min

• Acceptability of individual subtests and the complete test battery

  Acceptability will be estimated by the Average completion time for each subtest of the ENDI battery

  Through the study (completion of the full test battery), an average of 45 min

• Acceptability of individual subtests and the complete test battery

  Acceptability will be estimated by the Percentage of complete completion of each ENDI subtest

  Through the study (completion of the full test battery), an average of 45 min

• Acceptability of individual subtests and the complete test battery

  Acceptability will be estimated by the Percentage of subjects having completed all ENDI battery subtests

  Through the study (completion of the full test battery), an average of 45 min

Secondary Outcomes (4)

• The convergent validity of ENDI tests

  Through the study, an average of 16 months

• The convergent validity of ENDI tests

  Through the study, an average of 16 months

• The convergent validity of ENDI tests

  Through the study, an average of 16 months

• The convergent validity of ENDI tests

  Through the study, an average of 16 months

Study Arms (3)

Trisomy 21 patients

Trisomy 21 patients recruted on Main Phase will perform the ENDI tests in order to assess the acceptability of the subtests (individually) and the full neuropsychological battery

Diagnostic Test: ENDI (Neuropsychological Evaluation in Intellectual Disability)

Patients with Intellectual Disabilities

Patients with Intellectual Disabilities recruted on Preliminary Phase will be will carry out the ENDI tests in order to evaluate subtest design, ergonomics, understanding of instructions and identify any malfunctions. The observations gathered will enable the principal investigator to refine the digital design of the battery in collaboration with the publishing company.

Diagnostic Test: ENDI (Neuropsychological Evaluation in Intellectual Disability)

Normotypical volunteers

Normotypical volunteers recruted on Preliminary Phase will be will carry out the ENDI tests in order to evaluate subtest design, ergonomics, understanding of instructions and identify any malfunctions. The observations gathered will enable the principal investigator to refine the digital design of the battery in collaboration with the publishing company.

Diagnostic Test: ENDI (Neuropsychological Evaluation in Intellectual Disability)

Interventions

ENDI (Neuropsychological Evaluation in Intellectual Disability) DIAGNOSTIC_TEST

This neuropsychological battery comprises 15 subtests designed to assess language, memory, attention and executive skills. By analyzing changes in Trisomy 21 patients performance over time, the neuropsychologist can detect early signs of Alzheimer's disease.

Also known as: ENDI

Normotypical volunteers; Patients with Intellectual Disabilities; Trisomy 21 patients

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normotypical volunteers, patients with intellectual disability, and Trisomie 21 patients (T21) will be recruited by psychologists during a consultation in the Geriatrics Department of the University Hospital of Nancy, either through the Memory Resource and Research Center outpatient clinic or the day hospital. Volunteers and patients are generally referred by their general practitioner or another hospital department.

You may qualify if:

• Preliminary phase:
• Participant who has received full information on the organization of the research and has not objected to his or her participation and to the use of his or her data.
• Legal guardian of the participant, if applicable, who has received full information on the organization of the research and has not objected to participation and use of his/her data.
• Notion of intellectual disability in medical records
• Access to the oral language of the participant with an intellectual disability: the subject's speech must be comprehensible to the evaluator and the subject must be able to understand simple statements. It is not possible to use an oral comprehension test (e.g. Token test by Renzi \& Vignolo, 1962), as the norms achieved in healthy subjects would exclude almost all patients with intellectual disabilities, who have more limited language skills.
• Enrolled in or benefiting from a social security scheme.
• Participant having received full information on the organization of the research and not having objected to his or her participation and to the use of his or her data.
• Affiliation with a social security scheme or beneficiary of such a scheme
• Main phase:
• Participant with T21 who has received full information on the organization of the research and has not objected to participation and use of his/her data
• Legal guardian of the participant with T21, where applicable, who has received full information on the organization of the research and has not objected to his or her participation and the use of his or her data.
• Person with trisomy 21
• Access to the oral language of the participant with T21: the subject's speech must be comprehensible to the evaluator and the subject must be able to understand simple statements. It is not possible to use an oral comprehension test (e.g. Token test by Renzi \& Vignolo, 1962), as the norms achieved in healthy subjects would exclude almost all patients with intellectual disabilities, who have more limited language skills.
• Membership of a social security scheme or beneficiary of such a scheme

You may not qualify if:

• Disabling motor and/or sensory impairments preventing completion of the tests
• Insufficient command of the French language to complete the tests
• Severe general medical condition or alcoholism (habitual consumption of 3 drinks/day or history of alcohol withdrawal)
• History of stroke, severe head trauma, or cancer
• Change in long-term medication within 8 weeks prior to evaluation
• Refusal to participate by the subject and/or legal representative
• Individuals referred to in Articles L.1121-5 to L.1121-7 of the French Public Health Code:
• Pregnant women, women in labor, or breastfeeding mothers
• Individuals deprived of liberty by judicial or administrative decision
• Individuals undergoing psychiatric treatment under Article L.3213-1 of the French Public Health Code

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, Grand Est, 54511, France

Location

Related Publications (21)

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MeSH Terms

Conditions

Down Syndrome; Alzheimer Disease

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Amélie COQUELET, Psychologist

CONTACT

+33 3 83 15 79 64; a.coquelet@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: July 2, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

FR (1)