About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Other
Prospective
Treatments tested in this trial
ENDI (Neuropsychological Evaluation in Intellectual Disability)
Diagnostic testThis 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.
Treatment groups
Trial outcomes
Primary outcomes
Acceptability of individual subtests and the complete test battery
Acceptability will be estimated by The average completion time for the complete ENDI battery
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
Acceptability of individual subtests and the complete test battery
Acceptability will be estimated by the Percentage of complete completion of each ENDI subtest
Acceptability of individual subtests and the complete test battery
Acceptability will be estimated by the Percentage of subjects having completed all ENDI battery subtests
Secondary outcomes
The convergent validity of ENDI tests
Correlation coefficient between ENDI scores and scores on DSQIID-F questionnaire. Scoring scale for the DSQIID-F questionnaire is from 0 to 53
The convergent validity of ENDI tests
Correlation coefficient between ENDI scores and scores on BPSD-DS questionnaire . The Scoring scale for BPSD-DS questionnaire is : for each dimension, frequency is rated from 0 to 4 and severity from 0 to 3 .
The convergent validity of ENDI tests
Correlation coefficient between ENDI scores and score on ISDC questionnaire. Scoring scales for ISDC questionnaire is for each dimension, frequency is scored from 0 to 4, severity from 0 to 3 and impact from 0 to 5
The convergent validity of ENDI tests
Correlation coefficient between ENDI scores and scores of CAMCOG II questionnaire. The Scoring scale for CAMCOG II questionnaire is from 0 to 106, the lower the score, the greater the impairment.
Sponsors and contacts
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