Neuropsychological Evaluation in Intellectual Disability (ENDI)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-65
SponsorCentral Hospital, Nancy, France

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Trisomy 21 patients1 intervention
Group B: Patients with Intellectual Disabilities1 intervention
Group C: Normotypical volunteers1 intervention

Trial outcomes

Primary outcomes

1

Acceptability of individual subtests and the complete test battery

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

Time frame
Through the study (completion of the full test battery), an average of 45 min
2

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

Time frame
Through the study (completion of the full test battery), an average of 45 min
3

Acceptability of individual subtests and the complete test battery

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

Time frame
Through the study (completion of the full test battery), an average of 45 min
4

Acceptability of individual subtests and the complete test battery

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

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

Secondary outcomes

1

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

Time frame
Through the study, an average of 16 months
2

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 .

Time frame
Through the study, an average of 16 months
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

Time frame
Through the study, an average of 16 months
4

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.

Time frame
Through the study, an average of 16 months

Other outcomes

Sponsors and contacts

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