NCT07047963Not yet recruiting
Neuropsychological Evaluation in Intellectual Disability (ENDI)
Neuropsychological Evaluation in Intellectual Disability
Source: ClinicalTrials.gov · Last updated 2 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 22 May 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Central Hospital, Nancy, France
- Diseases
- Alzheimer disease
- NCT number
- NCT07047963
What you commit to
- Study type: Observational
- Planned participants: 40
- From 1 Jul 2025 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in long-term medication within 8 weeks prior to evaluation
Other illness
- 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
- 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
Other
- Disabling motor and/or sensory impairments preventing completion of the tests
- Insufficient command of the French language to complete the tests
- Refusal to participate by the subject and/or legal representative
Who the study is looking for
- Preliminary phase:
- The inclusion criteria for the group of people with intellectual disabilities are as follows:
- 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.
- Age at inclusion: ≥ 25 and ≤ 65 years
- 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.
- The inclusion criteria for the normotypic group are as follows:
- 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.
- Age at inclusion: ≥ 25 and ≤ 65 years
- 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
- Age at inclusion: ≥ 25 and ≤ 65 years
- 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
Age in the registry: 25 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHRU de Nancy Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.